BEUDAMED
    10 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 ×

    Rayvolve

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Smith & Nephew, Inc.·23596010103882·CHROME COBALT TROC WIRE .040 X 24 IN

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112984·CORNEAL TREPHINE BLADE9.5MM

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·September 20, 2002

    E-SCAN XQ

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART MRX-EMS DEFIBRILLATOR

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

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·August 6, 2014

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021