BEUDAMED
    12 results · 34ms · Sources: EU EUDAMED, US FDA

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    OPTIO-C ANTERIOR CERVICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UNKNOWN COOLSCULPTING SYSTEM

    FDA Adverse Event
    Injury ·ALLERGAN PLEASANTON·Product code OOK·July 12, 2021

    PC

    FDA UDI
    Allied Medical, LLC·00026072013625·ADPTR,M/S,C02,ISO 1/8" MPT

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M93051415002D10·#0 Cup Curette, Parallel Bayonet 90° REV ANG DWM

    YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS

    FDA 510(k)
    FDA Class 2 ·Neurology

    STARPACS ORTHOPEDICS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 4, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·June 1, 2011

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·August 8, 2023

    XP-CR Tibial Tray - Interlok 79 mm Item # 195276

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019