BEUDAMED
    13 results · 26ms · 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 ×

    Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Artman Instruments

    FDA UDI
    Wise Linkers, LLC·D1272424301·Baby Extraction Forceps Upper premolar Gold Plated

    Kerecis Reconstruct

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIFEPAK 15 monitor/defibrillator

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 23, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014

    CURRENT RF DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2011

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·July 23, 2013

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014