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

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    MissLan™ Digital Pregnancy Rapid Test

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517629876·CoRoent Ant TLIF Ti, 12x12x30mm 15°

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05714464010851·SONIC RADIANT 60 MNR T R BE

    HEALIX ADVANCE ORTHOCORD

    FDA UDI
    Medos International Sàrl·10886705021413·HEALIX ADVANCE PEEK ANCHOR w/ORTHOCORD PEEK Anc...

    MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CORIN TRINITY-I ACETABULAR SHELL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    4.5 HEALIX ADVANCE PEEK W/CORD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HWC·July 11, 2018

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    DIMENSION RXL MAX WITH HM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·November 3, 2014

    RELION PRIME BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·ARKRAY, INC.·Product code NBW·July 12, 2013

    4.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code HWC·August 10, 2018

    MITEK 5.5MM HEALIX ADVANCE PEEK ANCHOR W/ORTHOCORD

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code HWC·June 3, 2015

    MITEK 5.5MM HEALIX ADVANCE PEEK ANCHOR W/ORTHOCORD

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code HWC·April 12, 2015

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 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 L111, ESSENTIO DR SL MRI Pacemaker

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