BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    CARDIOPULMONARY BYPASS TUBING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489105619·PowerChem Neoprene Exam Gloves, Extra Small

    Sphero Attachment

    FDA UDI
    Preat Corporation·00842092113844·Sphero Block Abutment Straumann BL RC x 1mm (1....

    CODMAN

    FDA UDI
    Cerenovus, Inc.·20886704036491·CODMAN Surgical Patties 3/4 Inch x 3/4 Inch (1....

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78014011·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756016438·ARM SLING

    CODMAN®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780514978·CODMAN® Surgical Patties 3/4" x 3/4" (1.91cm x ...

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78014010101·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78014011001·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78014010051·Mini Sprint Bracket McLaugh/Benn/Trev. .022" ma...

    AMT THERAPEUTIC TABLE, MODEL 748AMT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MAYFIELD MR/X-RAY SKULL CLAMP

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD - 8010379·Product code KXA·May 8, 2014

    UNKNOWN LEFT REJUVENATE/ABG II HIP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 17, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 24, 2007

    Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp.·Product code HBA·September 20, 2024

    SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·November 6, 2024

    Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021