BEUDAMED
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    NUBIC SPINAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DISPOSABLE VITRECTOMY LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    QUIK-COMBO PACING/DEFIBRILLATION/ECG

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL CORP·Product code LDD·March 31, 1998

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·April 11, 2013

    HEARTSTREAM FR2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·March 1, 2011

    BIOMET CC CRUCIATE TRAY

    FDA Adverse Event
    Malfunction ·BIOMET, INC.·Product code JWH·May 20, 2008

    THORACIC PACK , Model No UTTC82Y UTTC82AA-01

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    OXYSURE

    FDA Adverse Event
    Injury ·OXYSURE·Product code CAW·March 19, 2014

    SEE H10

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDG·June 4, 2018

    OXYSURE

    FDA Adverse Event
    Injury ·OXYSURE·Product code DQA·March 19, 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