BEUDAMED
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    KODAK SURECELL HERPES (HSV) TEST KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MOBIL 02

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CYBERTENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    BMT SPLINED KNEE STM 18X160 BO

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 10, 2019

    VG 360 UNIV PST FM AUG 75X10

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBV·December 10, 2019

    VG 360 UNIV PST FM AUG 75X10

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBV·December 10, 2019

    VNGD SSK 360 L FEM 75MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·December 10, 2019

    SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 22, 2016

    FORTIFY DR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 19, 2014

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·October 25, 2010

    COULTER® LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·December 24, 2012

    Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189426 Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020

    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