BEUDAMED
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    POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902095986·TPRD LAP 14MM INSTR INNER TRAY

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00885556006955·PISTOL-GRIP DRILL

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTL.·Product code MNI·October 14, 2011

    PASS LP SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·December 31, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·September 23, 2014

    ENDO GIA ULTRA UNIVERSAL

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GDW·May 26, 2011

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    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

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024