BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    T-TYPE D-KAT, R-TYPE D-KAT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SBH

    FDA UDI
    SBH Surgical·00850068304011·1/1, Sterilization Container Perforated Lid, Bl...

    GC AADVA BO AC ABUTMENTS

    FDA 510(k)
    FDA Class 2 ·Dental

    IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·August 24, 2016

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    X8000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·May 10, 2011

    BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·January 5, 2021

    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

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023