BEUDAMED
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    AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    QCT Pro Asynchronous Calibration Module, CliniQCT

    FDA UDI
    MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694004190·BSSO Plate, 2.0mm System, Long

    FERRIS-SMITH TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896023796·FERRIS-SMITH TISSUE FORCEPS WITH TUNGSTEN CARBI...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694064941·2OS BSSO Long Plate Sterile Qty 5

    CRANEX BASEX D OR CRANEX EXCEL D

    FDA 510(k)
    FDA Class 2 ·Dental

    SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331

    FDA 510(k)
    FDA Class 2 ·Neurology

    LOGIC FEMORAL PS POR RIGHT SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 10, 2025

    LOGIC CR FEMORAL POR, LEFT, SZ 3.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 11, 2024

    ANTHEM RF

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

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 31, 2013

    LOANER SYSTEM 6 DT ROTARY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 17, 2011

    VASO VIEW HEMOPRO

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 15, 2019

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 26, 2023

    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