BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Medtronic Stedi Extra Support Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250075200·ceraMotion® Zr Transpa, 20 g / dental ceramic m...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250075400·ceraMotion® Zr Transpa, 40 g / dental ceramic m...

    3DMetal Diaphyseal Femoral Cones

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITEK 2 GRAM POSITIVE DAPTOMYCIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Widex

    FDA UDI
    Widex A/S·05706069895001·WIDEX EVOKE ERB0 (Lime green ) 100, RC coil, RI...

    Widex

    FDA UDI
    Widex A/S·05706069896169·WIDEX EVOKE EBB3D (Lime green ) 100, Telecoil, ...

    Widex

    FDA UDI
    Widex A/S·05706069896428·WIDEX EVOKE E-FS (Lime green ) 100, Telecoil, R...

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011

    BATTERY 14.8V, 6.3 AH LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 21, 2013

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013