BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Electrically Powered Wheelchair, Joy Rider

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112915·CORNEAL TREPHINE BLADE7.5MM

    COTTLE THUMB SKIN HOOK

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896077188·COTTLE THUMB SKIN HOOK WITH FINGER RING

    PUREIMAGE ULTRASOUND TRANSMISSION GEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T

    FDA 510(k)
    FDA Class 2 ·Immunology

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·December 21, 2005

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 3, 2014

    HEARTSTART MRX-EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALHCARE - ANDOVER·Product code MKJ·August 11, 2011

    UNIFY CRT-D

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·November 5, 2011

    LAPIPLASTY SYSTEM S4A

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code HRS·March 14, 2025

    AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw AI-0020 20mm AcuTwist¿ Acutrak Compression Screw AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw AI-0026 26mm AcuTwist¿ Acutrak Compression Screw AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw

    FDA Enforcement
    Class II ·Ongoing·Acumed LLC·January 4, 2023

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025