BEUDAMED
    23 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 ×

    Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112694·BARRON CORNEAL PUNCH 9.5MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112519·BARRON VACUUM TREPHINE 8.0MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112632·BARRON CORNEAL PUNCH 8.0MM

    KETAC-CEM IN REF. TO K802048

    FDA 510(k)
    FDA Class 2 ·Dental

    JBC OPAQUE AND GLITTER

    FDA 510(k)
    FDA Class 2 ·Dental

    INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    2 X 2 DUREPAIR DURA SUBSTITUTE

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code GXQ·July 27, 2012

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024118812·

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024118805·

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024118829·

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2015

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·August 14, 2017

    UNKNOWN STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWL·August 14, 2017

    UNKNOWN HEAD

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDI·August 14, 2017

    OXIMAX N-595 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·COVIDIEN FORMERLY TYCO HEALTHCARE·Product code DQA·October 15, 2008

    UNKNOWN

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code FTL·August 6, 2011

    ON-Q C-BLOC:400ML, 1-7 M./HR SAF, + 5ML/60MIN

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·June 27, 2013

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·December 19, 2018

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020