BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    CENTURION POCT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 28, 2025

    UNKNOWN HIP FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 2, 2019

    UNKNOWN HIP FEMORAL STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KXA·October 1, 2019

    UNKNOWN HIP ACETABULAR LINERS

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LZO·October 1, 2019

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·October 1, 2014

    VA LOCKSCR Ø2.4 SELF-TAP L18 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·May 29, 2013

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·June 16, 2011

    UNKNOWN HIP ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 1, 2019

    BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTM·December 18, 2013

    PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTC·April 30, 2020

    SILICONE INSERT F/INLINE PL CUTTER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTC·October 1, 2021

    BIODESIGN SURGISIS 4-LAYER TISSUE GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code FTM·December 18, 2013

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015