BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    TrapIt

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Kirwan

    FDA UDI
    KIRWAN SURGICAL PRODUCTS LLC·00841019100196·Disposable Bipolar Forceps 8 1/2" (21.6cm) Hard...

    LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLUCOMANAGER DATA MANAGEMENT SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008

    MONARCH PEDICLE SCREW

    FDA Adverse Event
    Injury ·DEPUY SPINE, INC.·Product code MNI·July 29, 2011

    SMALL CLIP APPLIER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 26, 2013

    BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·April 22, 2020

    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018