BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    Z5 Slit lamp microscope, Z2 Slit lamp microscope

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014539·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 35

    Bone Curette

    FDA UDI
    ELLIQUENCE, LLC·00846338005665·

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575209644·Knee tibia prosthesis trial - General Instrument

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575209675·Knee tibia prosthesis trial, reusable - Endo Mo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575209668·Knee tibia prosthesis trial, reusable - Endo Mo...

    LINK Instruments - Trial implants and size gauges

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575209651·Knee tibia prosthesis trial, reusable - Endo Mo...

    GENESIS REUSABLE RIGID CONTAINER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ADVANCE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code DXE·September 9, 2019

    PUREPOINT

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQF·October 6, 2014

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code DTQ·June 27, 2011

    SYRINGE 1.0ML 30GA 8MM 10BAG 500 PL/WG

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·January 28, 2021

    TR BAND

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

    TR BAND

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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