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

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    CloSYS® Dry Mouth Sensitive Mouth Rinse

    FDA 510(k)
    FDA Unclassified ·Unknown

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464090259·OTICON JET 1 BTE C093

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780434009·Integra® Jarit® Lambotte Mini Osteotome, With P...

    TAMARACK ANTERIOR THORACOLUNBAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Nautilus Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLIDEWELL HT IMPLANT Ø5.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 2, 2025

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·December 3, 2008

    COLLEAGUE

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

    ACCESS

    FDA Adverse Event
    Malfunction ·BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS·Product code FPA·July 26, 2013

    OSS POLY FEMORAL BUSHINGS 2PK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·October 10, 2019

    OSS 9CM DIAPHYSEAL SEGMENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·October 10, 2019

    OSS 5CM DIAPHYSEAL SEGMENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·October 10, 2019

    OSS TIBIAL POLY BEARING 14MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·October 10, 2019

    OSS POLY TIBIAL BUSHING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·October 10, 2019

    OT VERIO IQ METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 25, 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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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

    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