Is your device in the International Medical Devices Database? (2022)

174 devices with a similar name

Learn more about the data here

Device Recall Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths
  • Model / Serial

    11B15B611B23B711B28B911C09BA11C16B911C30B911C07B811B01B411B25B6

  • Product Classification

    Cardiovascular Devices

  • Device Class

    2

  • Implanted device?

    No

  • Distribution

    Worldwide Distribution - USA including AZ, AR, CA, CO, FL, GA, IL, KY, LA, MD, MA, MN, MO, NE, NJ, NM, NY, OH, OK PA, RI, TN, TX, UT, VA, WY, WI, and WV and the countries of BELGIUM, BRAZIL, CZECH REPUBLIC, FRANCE, GERMANY, GREAT BRITAIN, IRAQ, ITALY, NETHERLANDS, RUSSIAN FEDERATION, SOUTH KOREA, SPAIN, SWEDEN, and UKRAINE.

  • Product Description

    Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Ltd. 17148-6 Aza Kamekawa, Oaza Hichiya, Hyuga City, Miyazaki Prefecture 883-0062, Japan, Distributed by Boston scientific Corporation One Boston Scientific Place, Natick, MA 01760-1537 USA. || Super Sheath 8F x 11 cm ,038 with Guide Wire BX/10 UPN H7491603508B1, Catalog # 16035-08B. Batch/Lot 11B15B6, 11B23B7, 11B28B9, 11C09BA, 11C16B9, 11C30B9. || Super Sheath 8F x 11 cm ,038 without Guide Wire BX/10 , U PN M00115724B1, Catalog # 15-724B1. Batch/Lot 11C07B8. || Super Sheath R/O 8 F x 11 cm without Guide Wire BX/10, M00159664B1, Catalog # 15-964B, Batch/Lot 11B01B4, 11B25B6. || The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.

    (Video) How to use the International Medical Device Database | Implant FIles

  • Manufacturer

    Boston Scientific Corporation

Device Recall Boston Scientific Soloist
  • Model / Serial

    Soloist Single Needle M001262500 Reference Inner 14386589, 14435130, 14578709, 14629530, 14715963,Electrode -18cm (outer pouch Information) 14722621, 14776399, 14805361box)

  • Product Classification

    General and Plastic Surgery Devices

  • Device Class

    2

  • Implanted device?

    No

  • Distribution

    USA (nationwide) and the countries of Canada, Columbia, Viet Nam, Germany, France, Great Britain, Italy, Jordan, Kuwait, Netherlands Pakistan, Portugal, S. Arabia, Slovakia, Spain, Sweden and Tunisia.

  • Product Description

    Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick, MA. || The Soloist Needle Electrode is intended for use in conjunction with a Boston Scientific Corporation radiofrequency. (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

    (Video) Medical Device Searching, Part 2: Database Considerations

  • Manufacturer

    Boston Scientific Corporation

Device Recall Boston Scientific, IMAGER II Urology Torque Catheter
  • Model / Serial

    Imager" II Catheters C1 5fr 65cmM0064003001 M0064003000 Catalogue #400-300Lot/Batch Number: 00064016, 00065473, 00066117, 00067636, 00068586,00069553, 00070089, 00070791, 00071534, 00072320,00073679, 00073780, 00076129.Imager" II Catheters C2 5fr 65cmM0064003011 M0064003010 Catalogue #400-301Lot/Batch Number:00063007, 00064018, 00065474, 00066588, 00067128,00068068, 00073781, 00074282, 00075160, 00075362,00076130.Imager" II Catheters Straight 5fr 65cmM0064003021 M0064003020 Catalogue #400-302Lot/Batch Number:00063008, 00064020, 00065475, 00066590, 00067130,00068069, 00069554, 00071536, 00071619, 00073784,00074284, 00074829, 00075159.Imager" II Catheters Bern 5fr 65cmM0064003031 M00640030300Catalogue #400-303Lot/Batch Number:0064022, 00064918, 00065472, 00066119, 00066586,00067635, 00068584, 00068896, 00069555, 00069965,00070090, 00070789, 00071532, 00071617, 00072318,00073681, 00073778, 00074281, 00074828, 00076127.Imager" II Catheters JB1 5fr 65cmM0064003041 M0064003040Catalogue #400-304Lot/Batch Number:00064030, 00068587, 00069556, 00071535, 00071618,00073782, 00076131.Imager" II Catheters Straight 5fr 100cmM0064004021 M0064004020Catalogue #400-402Lot/Batch Number: 00066123, 00066589, 00068993, 00069557, 00070792,00072321, 00073783, 00074283, 00075363.Imager" II Catheters Bern 5fr 100cmM0064004031 M0064004030Catalogue #400-403Lot/Batch Number:00063006, 00064034, 00065926, 00070094, 00070788,00071616, 00073680, 00074827, 00076126.Imager" II Catheters JB1 5fr 100cmM0064004041 M0064004040Catalogue #400-404Lot/Batch Number: 00067129.Imager" II Catheters Bern 5fr 40cmM0064005031 M0064005030Catalogue #400-503Lot/Batch Number: 00064919, 00066121, 00066587, 00068585, 00068992,00070092, 00070790, 00071533, 00072319, 00073779,00075161, 00076128.

  • Product Classification
  • Device Class

    2

  • Implanted device?

    No

  • Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Arab Emir, Azerbaijan, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Bahrain, Bermuda, Brazil, White Russia, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Estonia, Egypt, Spain, Finland, France, Great Britain, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Ireland, Israel, Italy, Jordan, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Pakistan, Poland, Portugal, Qatar, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, El Salvador, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, Ukraine, Vietnam, South Africa, Dutch Antilles, Sri Lanka, Libya, and Yemen

  • Product Description

    Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. || The following products being recalled: || Imager" II Catheters C1 || 5fr 65cm || M0064003001 M0064003000 || 400-300 || Imager" II Catheters C2 || 5fr 65cm || M0064003011 M0064003010 || Catalog # 400-301 || Imager" II Catheters || Straight 5fr 65cm || M0064003021 M0064003020 || Catalog #400-302 || Imager" II Catheters || Bern 5fr 65cm || M0064003031 M0064003030 || Catalog #400-303 || Imager" II Catheters || JB1 5fr 65cm || M0064003041 M0064003040 || Catalog #400-304 || Imager" II Catheters || Straight 5fr 100cm || M0064004021 M0064004020 || Catalog #400-402 || Imager" II Catheters || Bern 5fr 100cm || M0064004031 M0064004030 || Catalog #400-403 || Imager" II Catheters || JB1 5fr 100cm || M0064004041 M0064004040 || Catalog #400-404 || Imager" II Catheters || Bern 5fr 40cm || M0064005031 M0064005030 || Catalog #400-503 || The Imager II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop", intended for use in the urinary tract.

    (Video) The EUDAMED database and EUDAMED logins

  • Manufacturer

    Boston Scientific Corporation

Device Recall Boston Scientific, IMAGER II Angiographic Catheter,
  • Model / Serial

    Catalog Number 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  • Product Classification

    Cardiovascular Devices

  • Device Class

    2

  • Implanted device?

    No

  • Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Arab Emir, Azerbaijan, Austria, Australia, Azerbaijan, Belgium, Bulgaria, Bahrain, Bermuda, Brazil, White Russia, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Ecuador, Estonia, Egypt, Spain, Finland, France, Great Britain, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Ireland, Israel, Italy, Jordan, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Malta, Mexico, Malaysia, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Pakistan, Poland, Portugal, Qatar, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, El Salvador, Syria, Thailand, Tunisia, Turkey, Trinidad, Tobago, Taiwan, Ukraine, Vietnam, South Africa, Dutch Antilles, Sri Lanka, Libya, and Yemen

  • Product Description

    Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537. || The following product is being recalled: || "Material Number/(OUTER CARTON LABEL OF 5pk)"/"Material Number || (INNER-POUCH LABEL FOR EACH SINGLE CATHETER)"/ Material Description/ Catalog Number. || M001314001M001314000IMAGER II/5/ST/65/038 BX531-400 || M001314011M001314010IMAGER II/5/ST/100/038 BX531-401 || M001314021M001314020IMAGER II/5/ST/65/035 BX 531-402 || M001314031M001314030IMAGER II/5/ST/100/035 BX 531-403 || M001314041M001314040IMAGER II/5/BARNH/100/038 BX531-404 || M001314051M001314050IMAGER II/5/BERN/100/038 BX531-405 || M001314061M001314060IMAGER II/5/BERN/100/035 BX 531-406 || M001314071M001314070IMAGER II/5/BERN/40/035 BX 531-407 || M001314081M001314080IMAGER II/5/BERN/40/038 BX531-408 || M001314091M001314090IMAGER II/5/BERN/65/035 BX 531-409 || M001314101M001314100IMAGER II/5/BERN/65/038 BX531-410 || M001314111M001314110IMAGER II/5/WEIN/100/038 BX531-411 || M001314121M001314120IMAGER II/5/WEIN/100/035 BX 531-412 || M001314131M001314130IMAGER II/5/H1/65/038 BX531-413 || M001314141M001314140IMAGER II/5/H1/100/038 BX531-414 || M001314151M001314150IMAGER II/5/H1/100/035 BX 531-415 || M001314161M001314160IMAGER II/5/H3/100/038 BX531-416 || M001314171M001314170IMAGER II/5/H3/100/035 BX 531-417 || M001314181M001314180IMAGER II/5/H1H/100/038 BX531-418 || M001314191M001314190IMAGER II/5/H1H/100/035 BX 531-419 || M001314201M001314200IMAGER II/5/H3H/100/035 BX 531-420 || M001314211M001314210IMAGER II/5/JB1/65/038 BX531-421 || M001314221M001314220IMAGER II/5/JB1/100/038 BX531-422 || M001314231M001314230IMAGER II/5/JB1/100/035 BX 531-423 || M001314241M001314240IMAGER II/5/JB2/100/038 BX531-424 || M001314251M001314250IMAGER II/5/JB2/100/035 BX 531-425 || M001314261M001314260IMAGER II/5/JB3/100/038 BX531-426 || M001314271M001314270IMAGER II/5/JB3/100/035 BX 531-427 || M001314281M001314280IMAGER II/5/MAN/100/038 BX531-428 || M001314291M001314290IMAGER II/5/MAN/100/035 BX 531-429 || M001314301M001314300IMAGER II/5/SIM1/65/038 BX531-430 || M001314311M001314310IMAGER II/5/SIM1/65/035 BX 531-431 || M001314321M001314320IMAGER II/5/SIM1/100/038 BX531-432 || M001314331M001314330IMAGER II/5/SIM1/100/035 BX 531-433 || M001314341M001314340IMAGER II/5/SIM2/100/038 BX531-434 || M001314351M001314350IMAGER II/5/SIM2/100/035 BX 531-435 || M001314361M001314360IMAGER II/5/SIM3/100/038 BX531-436 || M001314371M001314370IMAGER II/5/SIM3/100/035 BX 531-437 || M001314381M001314380IMAGER II/5/SIM4/100/038 BX531-438 || M001314391M001314390IMAGER II/5/HN1/100/038 BX531-439 || M001314401M001314400IMAGER II/5/HN1/100/035 BX 531-440 || M001314411M001314410IMAGER II/5/HN2/100/038 BX531-441 || M001314421M001314420IMAGER II/5/HN2/100/035 BX 531-442 || M001314431M001314430IMAGER II/5/HN3/100/038 BX531-443 || M001314441M001314440IMAGER II/5/HN3/100/035 BX 531-444 || M001314451M001314450IMAGER II/5/HN4/100/038 BX531-445 || M001314461M001314460IMAGER II/5/HN4/100/035 BX 531-446 || M001314471M001314470IMAGER II/5/HN5/100/038 BX531-447 || M001314481M001314480IMAGER II/5/HN5/100/035 BX 531-448 || M001314491M001314490IMAGER II/5/CK/100/035 BX 531-449 || M001314501M001314500IMAGER II/5/GEN/100/035 BX 531-450 || M001314511M001314510IMAGER II/5/GEN+2 SIDEHOLES/100/035 BX 531-451 || M001314521M001314520IMAGER II/5/CHGB/65/038 BX531-452 || M001314531M001314530IMAGER II/5/CHGB/65/035 BX 531-453 || M001314541M001314540IMAGER II/5/CHGC/65/038 BX531-454 || M001314551M001314550IMAGER II/5/CHGC/65/035 BX 531-455 || M001314561M001314560IMAGER II/5/CHG2.5/65/038 BX531-456 || M001314571M001314570IMAGER II/5/CHG2.5/65/035 BX 531-457 || M001314581M001314580IMAGER II/5/CONTRA 2/65/038 BX531-458 || M001314591M001314590IMAGER II/5/CONTRA 2/65/035 BX 531-459 || M001314611M001314610IMAGER II/5/DUCK/65/035 BX 531-4

    (Video) FDA's MAUDE database: A medical device expert's insight

  • Manufacturer

    Boston Scientific Corporation

Device Recall Boston Scientific Profile SingleUse Pediatric Snare

169 more

FAQs

How do I know if my medical device is FDA approved? ›

Go to the Device Classification Under Section 513(f)(2)(De Novo) database.
...
To search for FDA-approved or FDA-cleared products by device name or company name:
  1. Go to the Devices@FDA Database.
  2. In the Enter a search term in the space below field, type the name of the device or the company name. ...
  3. Click Search.
3 Mar 2021

What is considered a medical device in the EU? ›

Medical devices are products or equipment intended for a medical purpose. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended.

What is a medical device data System? ›

Medical Device Data Systems (MDDS) are hardware or software products intended to transfer, store, convert formats, and display medical device data. A MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device.

What is a medical device MHRA? ›

The MHRA determines whether a product falls within the definition of a medicine – 'medicinal product' or a medical device and provides information on whether a product is a medicine or a medical device or not.

Do all medical devices need FDA approval? ›

Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use.

What is an example of a medical device? ›

Examples are ultrasound and MRI machines, PET and CT scanners, and x-ray machines. Treatment equipment includes infusion pumps, medical lasers and LASIK surgical machines. Life support equipment is used to maintain a patient's bodily function.

How do you determine if your product is a medical device? ›

To determine if your product meets the definition of a medical device, you should define the intended use and indications for use of your product. Once you have defined the intended use and indications for use of your product, you can determine if the product meets the definition of a medical device.

What makes something a medical device? ›

A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.

What is device data? ›

Device data definition (noun)

Device data refers to data collected from a computer, browser, phone, tablet, or another electronic device. This data is often used to analyze user behaviors and predict future preferences or interests.

Is an EHR a medical device? ›

Gottlieb said the best approach might be to say that an EHR that has a certain capability becomes a medical device. He called EHRs a “unique tool,” noting that the risks posed by their use aren't the same as for a traditional medical device implanted in a patient.

What is MDDS in medical terms? ›

In practice, a medical device data system (MDDS) is a medical device intended to provide one or more of the following functions: The electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.

Does UK follow MDR? ›

Registrations in Great Britain

In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA .

How do you classify a medical device? ›

Classification of Medical Devices

The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.

Who is responsible for medical device reporting? ›

Device User Facility Reporting Requirements

User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown. User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33.

What are the three classifications of medical devices? ›

There are 3 classes of medical devices:
  • Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.
  • Class II devices are intermediate-risk devices. ...
  • Class III devices are high-risk devices that are very important to health or sustaining life.

How do medical devices get approved? ›

There are 3 basic processes to obtain FDA marketing approval for medical devices, depending on the nature of the device and the circumstances under which approval is sought: 1) the PMA process; 2) the PMN process; and 3) the humanitarian device exemption (HDE) process.

What are 3 different types of applications for medical devices submitted to the FDA? ›

The most common types of premarket submissions include: 510(k) (Premarket Notification) PMA (Premarket Approval) De Novo Classification Request.

Is a toothbrush a medical device? ›

The term 'medical device' covers a variety of products. Examples include: toothbrushes, bandages, knee implants, blood glucose meters, surgical instruments, and pacemakers.

Is Apple watch a medical device? ›

The latest iteration of Apple's smartwatch includes an FDA-cleared electrocardiogram, officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms.

What is a Class 1 medical device? ›

Class 1 medical devices are devices with low or moderate risk to patient health and safety. 47% of approved medical devices are Class 1, and 95% of these devices are exempt from the PMA pathway to regulatory approval. Class 1 device manufacturers are required to register their device with the FDA, however.

Is fitbit a medical device? ›

Unless otherwise specified, Fitbit products and services are not a medical devices, and are not intended to diagnose, treat, cure or prevent any disease. With regard to accuracy, Fitbit has developed products and services to track certain wellness information as accurately as reasonably possible.

What is the difference between medical device and medical equipment? ›

Intuitively, all medical equipment are medical devices—but not all devices should be considered equipment. For example, implants and single-use devices are clearly not equipment that needs to be inventoried or repaired occasionally, as they leave the institution with the patient or are discarded after use.

Do medical devices need to be CE marked? ›

CE marking is mandatory, even if the medical device was manufactured outside the EEA. It is the manufacturer's sole responsibility to obtain and place the CE mark on the product. If the product is imported from outside the EEA, then this responsibility falls to the importer within the community.

What is not medical device? ›

medical - toiletry purpose

The definition of "medical device" should be understood to include products intended to be used principally for a medical use. Therefore products intended to have a toiletry or cosmetic purpose are not medical devices even though they may be used for prevention of a disease.

Is air purifier a medical device? ›

The FDA categorizes air purifiers as Class II medical devices. Whereas Class III medical devices require FDA premarket approval, Class II medical devices only require clearance.

Is an adult diaper a medical device? ›

The definition of medical devices is wide and diverse but it does not cover all products aimed at elderly people. For example, it would not include adult diapers, but it will cover blood pressure monitors.

What is a medical device registration? ›

What are the FDA medical device registration and listing requirements? The purpose of registering and listing a medical device is to provide FDA with the location of all facilities involved in the manufacture of a medical device, including what is being manufactured and where.

How many EU countries are impacted by MDR? ›

The European Commission's Nando database currently lists 20 notified bodies designated under MDR.

What needs to be done if your product is going to the EU? ›

satisfy any traceability requirements: preserve the technical documentation and the EU declaration of conformity (for 10 years after the product is placed on the market or for the period specified for that product under EU law) give the product a type, batch or serial number for identification.

What is included in device data? ›

More Definitions of Device Data

Device Data means data collected from an IP address, web beacon, pixel tag, ad tag, cookie, JavaScript, local storage, software, or by any other means, or from a particular computer or other device or application.

What data do smart devices collect? ›

Smart devices collect a wide range of data about their users. Smart security cameras and smart assistants are, in the end, cameras and microphones in your home that collect video and audio information about your presence and activities.

Can Internet data be stored? ›

Due to the nature of the Internet as a network, the conventional answer is that, no, it's not possible. The Internet is nothing but a network of interconnected computers, and you can't store a network on your device.

Who regulates electronic health records? ›

ONC is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information.

Why are electronic health records controversial? ›

Patient harm: Electronic health records have created a host of risks to patient safety. Alarming reports of deaths, serious injuries and near misses — thousands of them — tied to software glitches, user errors or other system flaws have piled up for years in government and private repositories.

Who uses health record data? ›

EHRs are built to share information with other health care providers and organizations – such as laboratories, specialists, medical imaging facilities, pharmacies, emergency facilities, and school and workplace clinics – so they contain information from all clinicians involved in a patient's care.

How do I get rid of MdDS? ›

Until now, there has been no effective treatment for MdDS. Diagnostic tests and early research done at Mount Sinai suggested that MdDS was caused by malfunctioning of the vestibule-ocular reflex (VOR), a mechanism in the inner ear that maintains balance and stabilizes the eyes during head movements, said Dr. Cohen.

How do you know if you have MdDS? ›

What are the symptoms of MdDS? The symptoms of mal de debarquement include the sensation of rocking, bobbing or swaying; along with unsteadiness, anxiety and loss of self confidence. The symptoms often increase when the person is trying to remain motionless for example attempting to fall asleep or standing still.

What triggers MdDS? ›

The most common triggers are water-based activities such as ocean cruising. Less common triggers include airplane travel, extended landing travel and sleeping on water beds.

Who does EU MDR apply to? ›

Compliance with this regulation is mandatory for medical device companies (legal manufacturers) that want to market or sell their products in the EEA (European Economic Area). There are 27 EU member countries. The EU MDR in its entirety is applicable to finished medical devices.

Who approves medical devices in UK? ›

In the UK the competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA). The Medical Devices Directive (93/42/EEC) classifies products according to their level of risk. Manufacturers must make sure they comply with all the legislation's relevant essential requirements.

Who regulates medical devices in Europe? ›

The European Commission published MDCG 2019-7, guidance on the person responsible for regulatory compliance (PRRC). The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to medical devices for the European market.

How do you classify a medical device in Europe? ›

The MDR designates four medical device classifications: Class I. Class IIa. Class IIb.
...
Class I Medical Devices
  1. Class Is: The medical device must be presented sterile.
  2. Class Im: The medical device has a measuring feature.
  3. Class Ir: The medical device is a reusable surgical instrument.
23 Jul 2021

What are Class I II and III medical devices MDR? ›

Class I – Provided sterile and/or have a measuring function (low/medium risk); the MDR adds to this group, reusable surgical instruments as Class I reusable surgical instruments. Class IIa (medium risk) Class IIb (medium/high risk) Class III (high risk)

What is the difference between a Class 1 and Class 2 medical device? ›

FDA Medical Device Classifications

Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate to high risk that requires special controls.

Where are MDR policies kept? ›

Searching Medical Device Reports

The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

What are MDR reportable events? ›

An MDR reportable event is a death, a serious injury, or, if you are a manufacturer or importer, a malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

What is the difference between MDD and MDR? ›

The MDD mentions the conduct of PMS and PMCF but provides no detailed requirements. The MDR provides requirements for a PMS system within the manufacturer's QMS and the uses for the data gathered.

What medical devices are FDA approved? ›

Medical Devices Cleared or Approved by FDA in 2021
Device NameCategory
Organ Care System (OCS) Heart System - P180051Transplant
RADIESSE (+) Lidocaine Injectable Implant - P050052/S129Implant
Oncomine Dx Target Test - P160045/S028Laboratory Test
VENTANA MMR RxDx Panel - P210001Laboratory Test
21 more rows

How do I verify my FDA certificate online? ›

consumers access to safe and quality commodities in the market. The FDA wishes to inform th public that is now Accessible through the website link https://verification.fda.gov.ph.

What is considered a medical device by the FDA? ›

It can be found in Section 201(h) of the Federal Food, Drug, and Cosmetic Act. It's a very broad definition. It basically says a medical device is “any instrument, machine, contrivance, implant, in vitro reagent that's intended to treat, cure, prevent, mitigate, diagnose disease in man”.

How does FDA classify medical devices? ›

The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness.

What are the three classifications of medical devices? ›

There are 3 classes of medical devices:
  • Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.
  • Class II devices are intermediate-risk devices. ...
  • Class III devices are high-risk devices that are very important to health or sustaining life.

Is the Covid vaccine FDA approved? ›

Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination.

How many medical devices are there? ›

Today, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups.

How do I find my medical device listing number? ›

A firm's registration or owner/operator number can be found in the Public Registration and Listing database at https:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm. However, medical device listing number(s) are not available publicly.

What does FDA certified mean? ›

New drugs and biological products for people must be FDA approved before they are marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.

How do you tell if your product is a medical device? ›

To determine if your product meets the definition of a medical device, you should define the intended use and indications for use of your product. Once you have defined the intended use and indications for use of your product, you can determine if the product meets the definition of a medical device.

What are 3 different types of applications for medical devices submitted to the FDA? ›

The most common types of premarket submissions include: 510(k) (Premarket Notification) PMA (Premarket Approval) De Novo Classification Request.

Is a toothbrush a medical device? ›

The term 'medical device' covers a variety of products. Examples include: toothbrushes, bandages, knee implants, blood glucose meters, surgical instruments, and pacemakers.

Is Apple watch a medical device? ›

The latest iteration of Apple's smartwatch includes an FDA-cleared electrocardiogram, officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms.

How do I register a medical device in USA? ›

List your device and register your company using FURLS system on the FDA website; pay fees for Establishment Registration and Listing, which must be renewed each year. You are now able to sell your device in the US. Your company and device registration status will be listed on the FDA website.

Who is responsible for medical device reporting? ›

Device User Facility Reporting Requirements

User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown. User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33.

Videos

1. Know Your Medical Device Why the Unique Device Identification UDI System Should Matter to You
(CreakyJoints)
2. Webinar about EUDAMED MODULE 2
(Asphalion)
3. Medical Devices: Generating and Using Real-World Observational Data for Decision-Making on Value
(CADTHACMTS)
4. European Database for Medical Devices (EUDAMED) Registration
(Maven Profcon Services LLP)
5. How to register your company in EUDAMED? [Medical Devices]
(Easy Medical Device)
6. Introduction to the UDI System in the USA
(Emergo by UL Solutions)

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