BEUDAMED
    16 results · 21ms · 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 ×

    GARAVENTA X3 INCLINED PLATFORM LIFT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756612562·Wrist Splint

    DURAVENT

    FDA UDI
    Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948007367·DURAVENT UNI XL 1 IC + 1 ICU, SIZE 6

    Peerless Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053296·PEERLESS 2NDMOL 6DEG LL NDX-27TX018

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383505949·Gutta Percha Points is used to root canal filin...

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180516010·ALIF, 45° Push Cup Curette, Size 02

    ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JENSEN GOLD FOIL

    FDA 510(k)
    FDA Class 2 ·Dental

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 18, 2019

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·May 17, 2013

    INSYNC SENTRY

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code NIK·June 13, 2011

    UNK CERAMIC ON CERAMIC HIP

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS CORK·Product code MRA·May 1, 2008

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·February 11, 2026

    The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.

    FDA Enforcement
    Class II ·Ongoing·Ithera Medical Gmbh·February 19, 2025

    IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part #1990S; International Biophysics Corp., Austin, TX.

    FDA Recall
    Terminated ·International Biophysics Corp·Product code DWE·August 16, 2005

    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 31404-44, 31404-46, 31404-48, 31404-50, 31404-55, 31404-60, 31404-65, 31404-70, 31404-75, 31404-80, 31457-30, 31457-36, 31457-40, 31457-46, 31457-50, 31457-55, 31457-60, 31652-100, 31652-105, 31652-110, 31652-115, 31652-120, 31652-25, 31652-30, 31652-35, 31652-40, 31652-45, 31652-55, 31652-60, 31652-65, 31652-70, 31652-75, 31652-80, 31652-85, 31652-90, 31652-95, 31731-100, 31731-105, 31731-110, 31731-115, 31731-120, 31731-50, 31731-60, 31731-65, 31731-70, 31731-75, 31731-80, 31731-85, 31731-90, 31731-95, 31732-60, 31734-100, 31734-105, 31734-110, 31734-115, 31734-120, 31734-45, 31734-50, 31734-60, 31734-65, 31734-70, 31734-75, 31734-80, 31734-85, 31734-90, 31734-95. 2. Cortical Screw, Cannulated; Article Numbers: 31357-44, 31357-22, 31357-48, 31277-18, 31357-20, 31357-22, 31357-24, 31357-26, 31357-28, 31357-30, 31357-32, 31357-34, 31357-36, 31357-38, 31357-40, 31357-42, 31357-44, 31357-46, 31357-48, 31357-60, 31357-65, 31357-70. 3. Washer; Article Number: 36851. 4. Washer, Concave; Article Numbers: 36432, 36653, 36732. 5. Washer, Flat; Article Numbers: 36431, 36651, 36653, 36731.

    FDA Enforcement
    Class II ·Ongoing·I.T.S. GmbH·April 1, 2026