BEUDAMED
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    PRE-REDUCED ANAEROBIC MEDIA

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ALIF

    FDA UDI
    Nuvasive, Inc.·00887517622006·ALIF Interfixated Screw, 6.0x25.0mm Var

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515200777·Kolbel Soft Tissue Retr,single prng, straight, 7"

    Performa®

    FDA UDI
    Merit Medical Systems, Inc.·00884450003152·

    GVC-100

    FDA 510(k)
    FDA Class 2 ·Dental

    MAGNETOM Terra

    FDA 510(k)
    FDA Class 2 ·Radiology

    PLUM A+ DRIVER NEW 8

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 18, 2014

    MONOCRYL PLUS ANTIBACTERIAL SUTURES

    FDA Adverse Event
    Malfunction ·ETHICON, INC·Product code GAN·October 3, 2012

    PROSTHESIS, INTERVERTEBRAL DISC

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code MJO·May 14, 2015

    Aimshot HeatSeeker Model HS3500, contains Class IIIb infared laser illuminator. Amstech Incorporated, Alpharetta, GA 30022. Targeting, detecting heated areas, searches.

    FDA Recall
    Terminated ·Amstech Incorporated·Product code REP·August 17, 2010

    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

    Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021