BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    Graftgun Universal Graft Delivery System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197071895·PARKER MOTT retractor set 16.0cm...

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 15, 2021

    EASYRA UREA NITROGEN AND CREATININE REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAMMAPRINT

    FDA 510(k)
    FDA Class 2 ·Immunology

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019

    CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

    CHLORAPREP ONE STEP HI-LITE ORANGE

    FDA Adverse Event
    Malfunction ·Product code KXF·October 4, 2021

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·June 14, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 11, 2011

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·September 16, 2008

    CD HORIZON® SOLERA® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·December 30, 2025

    CD HORIZON® SOLERA® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·June 10, 2025

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code NKB·January 22, 2026

    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 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