BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049804·Steinmann Pins, Double diamond, 5/64-inch (2.0m...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293630·

    mahe medical GmbH

    FDA UDI
    mahe medical gmbh·04050659485020·Steinmann pin w. double end lanzet point_x000D_...

    Steinmann pin w. double end lanzet point 2.0mm/229mm, 6 pcs./unit

    FDA UDI
    mahe medical gmbh·EMAHKM716000·Steinmann pin w. double end lanzet point 2.0mm/...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111115608·BONE FILE ANG S/E INSIDE CUT

    ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Radiology

    Renal Access Cobra Catheter, Kumpe Access Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENDOPATH DILATING TIP TROCAR

    FDA Adverse Event
    Injury ·EES-JUAREZ·Product code GCJ·March 14, 1997

    EUROHEALTH LARGE ORGAN RETRACTOR

    FDA Adverse Event
    Malfunction ·EUROHEALTH SYSTEMS·Product code KNS·March 5, 1997

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·January 30, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·January 25, 2011

    UNKNOWN DEPUY PERIPHERAL SCREW

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HWC·July 31, 2014

    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