BEUDAMED
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    ADHERENT VISUAL STIMULATOR GOGGLES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Dandy Clear Aligners

    FDA UDI
    Orthly, Inc.·00860006891206·

    Stablecut®

    FDA UDI
    SYNVASIVE TECHNOLOGY, INC.·00846795006380·

    Stablecut®

    FDA UDI
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024494275·

    GLOBAL

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295007241·GLOBAL ENDURON PE SHOULDER - GLENOID PEG SIZE 44

    MOBILE MIM

    FDA 510(k)
    FDA Class 2 ·Radiology

    UROVYSION BLADDER CANCER RECURRENCE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    2.0MM DRILL BIT/QC/100MM

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HWE·March 2, 2017

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 15, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 24, 2014

    HEALIX 5.5MM BR ANCHOR

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code MBI·June 2, 2011

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

    IMP TM 4.1MM MTX FULL, 11.5MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·May 13, 2022

    IMP TM 4.7MM MTX FULL, 10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 30, 2024

    BD ANGIOCATH PNK 20GA X 1.88IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·February 10, 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

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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