BEUDAMED
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    REVEEL ENDOSCOPIC RETRACTOR

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

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517637154·CoRoent Ant TLIF PEEK, 13x13x34mm 15°

    Oticon

    FDA UDI
    Oticon A/S·05707131260376·H10, MINIBTE 312 WL 85 DBL

    ATRAMAT

    FDA UDI
    Internacional Farmacéutica, S.A. de C.V.·07500142063756·ATRAMAT SILK SURGICAL SUTURE BLACK USP 3-0 EP 2...

    GMK-SPHERE FEMORAL COMPONENT CEMENTED # 4 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL, SA·Product code JWH·July 31, 2015

    AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Radiology

    BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013

    ENDOPATH** XCEL* TROCAR

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·June 20, 2011

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP EX SHORT

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·August 22, 2008

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

    Philips Respironics DreamWear Full Face Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

    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