BEUDAMED
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    AERODR SYSTEM 2

    FDA 510(k)
    FDA Class 2 ·Radiology

    Regenerex

    FDA UDI
    Biomet Orthopedics, LLC·00880304463622·

    CA CAL S

    FDA UDI
    SYSMEX CORPORATION·04987562516797·The product is applied to calibrate the sensiti...

    HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX

    FDA 510(k)
    FDA Class 2 ·Hematology

    STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BIOMET TIBIAL LOCKING BAR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 6, 2020

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·October 3, 2014

    WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code MUM·June 27, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 3, 2013

    VANGUARD CRUCIATE RETAINING TIBIAL BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·December 6, 2016

    BIOMET FINNED PRI STEM 40MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 6, 2020

    E1 VNGD PS TIB BRG 63/67X16 X 16

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 6, 2020

    RGX 3 PEG SER A PATELLA 28MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 6, 2020

    VANGUARD CR POR FEM-RT 62.5

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 10, 2020

    VNGD ANT STBLZD BRG 12X63

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 10, 2020

    MODULAR SPLINED STEM 40MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·November 10, 2020

    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

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012