BEUDAMED
    19 results · 20ms · 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 ×

    GLOBALCARDIO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517577092·CoRoent Ant TLIF PEEK, 11x11x32mm 0°

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK111201·DD tempMED are pre-colored dental milling blank...

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK113201·DD tempMED are pre-colored dental milling blank...

    Stryker®

    FDA UDI
    Microtek Medical LLC·00748426143757·Mako™ Drape Kit

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321113200·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311113200·

    24G X 0.75IN (0.7 X 19 MM) ANGIOCATH

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·July 28, 2017

    VASOVAPOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OFFSET 30 DEGREES BROACH HANDLE - LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code GET·July 10, 2014

    NON21430CNS

    FDA Adverse Event
    MEDLINE INDUSTRIES INC·Product code GDY·April 29, 2013

    CAD II

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·September 23, 2014

    ZOOM CRITICAL CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 18, 2011

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 12, 2016

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018