BEUDAMED
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    SiJoin®T3

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RIGIDFIX

    FDA UDI
    DEPUY MITEK, LLC·10886705003266·RIGIDFIX TIBIAL ROD Bone Tendon Bone Only 11.5m...

    CADD

    FDA UDI
    ICU MEDICAL, INC.·00610586017073·

    MEDRAD QWIK-FIT SYRINGE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESSCAN

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HEARTSTREAM XL

    FDA Adverse Event
    PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 22, 2008

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 17, 2011

    NEXTEN LPS-FLEX ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·July 3, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    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