BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    SYNERGETICS DIRECTIONAL ENDOOCULAR LASER PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642105407·PS3 Screw 8.5mm x 55mm

    AIMSTEP PREGNANCY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HEARTMATE 14V POWER MODULE PATIENT CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·May 7, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

    ARCHITECT IPTH

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code CEW·June 3, 2011

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2026

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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