BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    Bernafon

    FDA UDI
    Bernafon AG·05711584086681·ZR3, KIT 312 2.4G NFM 85 R BE ZERENA 3

    MOUNTAINEER LAMINOPLASTY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    APEX KNEE MODULAR TIBIA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CD SPINAL SYSTEM

    FDA Adverse Event
    Injury ·SOFAMOR DANEK EUROPE·Product code KWQ·February 19, 1999

    DATASCOPE

    FDA Adverse Event
    Injury ·DATASCOPE CORP.·Product code DSP·July 29, 1994

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·October 18, 2005

    CADD-1 PUMP

    FDA Adverse Event
    Death ·PHARMACIA DELTEC, INC.·Product code FRN·May 12, 1994

    SOFTJAW 6MM SPRING CLIP

    FDA Adverse Event
    Injury ·BAXTER·February 21, 1995

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    FDA Adverse Event
    Injury ·DOW CORNING CORP.·Product code FTR·March 7, 1998

    IABP TUBING MODEL S50HL

    FDA Adverse Event
    Malfunction ·ARROW/KONTRON INSTRUMENTS·Product code DWE·March 7, 1995

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CRMD·Product code DTB·January 13, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 27, 2013

    MONOFOCAL IOLS

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·June 19, 2012

    BD KIESTRA IDENTIFA

    FDA Adverse Event
    Malfunction ·BD KIESTRA LAB AUTOMATION·Product code QBN·October 8, 2025

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·October 18, 2019

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 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