BEUDAMED
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    INQWIRE DIAGNOSTIC GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VACCESS LT LONG-TERM HEMODIALYSIS CATHETER PLUS

    FDA UDI
    Bard Access Systems, Inc.·00801741010873·VACCESS PLUS, ST, 16 FR. 23cm

    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

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197411929·Thorek dissecting scissors curved...

    TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA

    FDA 510(k)
    FDA Class 2 ·Neurology

    AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·October 1, 2014

    ARRAY IMPLANTS

    FDA Adverse Event
    Malfunction ·EBI, LLC·Product code MNI·June 20, 2011

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 26, 2026

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 9, 2022

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·April 12, 2018

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·October 10, 2017

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 20, 2019

    smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024

    GMK SPHERE FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 22, 2017

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 11, 2020

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 27, 2020

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 13, 2020

    DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·August 10, 2023