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    THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE

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

    K152468

    FDA UDI
    Shenzhen Vistar Medical Supplies Co.,Ltd.·96973521874184·Reusable NIBP cuff,Thigh,single tube, HP connector

    ARGEDENT 40SF

    FDA UDI
    ARGEN CORPORATION, THE·D818112468·Gold based noble metal

    TLIF/PLIF Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837087067·

    ASSI

    FDA UDI
    ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION·00841645119340·Parkes Rasp 21cm, Extremely Coarse Grit No.8, T...

    MODIFICATION TO N/T PROTEIN CONTROL SL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ZOLL PROPAQ MD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AWL Ø2 ANGL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·January 8, 2013

    AWL Ø2 ANGL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·January 7, 2013

    AWL Ø2 ANGL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·January 7, 2013

    M2A-MAGNUM MOD HD SZ 42MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 14, 2013

    ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·June 3, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025