BEUDAMED
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    Clear Guide SCENERGY

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699564·GENUMEDI PSS BLUE, SIZE IV

    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

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014584·CALIBRA 1ST MOL BANDS W/G8325-03 n.UL 4

    Anatotemp

    FDA UDI
    BUCKEYE MEDICAL TECHNOLOGIES, LLC·D7861530040·Anatotemp Anatomic Dental Implant Healing Abutm...

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100271·SAUER INFANT SPECULUM

    VARIANT

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1530040·WOLF Adaptor

    MSAS-VANTAGE

    FDA 510(k)
    FDA Class 2 ·Neurology

    SNORE GUARD

    FDA 510(k)
    FDA Class 2 ·Dental

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 8, 2013

    VASOVIEW HEMOPRO EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·June 17, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008

    Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.

    FDA Enforcement
    Class II ·Terminated·Ethicon, Inc.·December 18, 2013

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020

    GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 3, 2025

    RADIFOCUS GUIDEWIRE ADVANTAGE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 12, 2024

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·August 7, 2020