BEUDAMED
    15 results · 25ms · 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.

    PosiSep EAR Fragmentable Ear Dressing

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    IMAGEN Parainfluenza Virus Types 1, 2 and 3

    FDA UDI
    OXOID LIMITED·05032384502974·

    A-CIFT® SoloFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361037149·SLIM GUIDE, SLIM PEEK INSERTER - 11MM

    5210411

    FDA Adverse Event
    Malfunction ·November 9, 2015

    PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ATAMA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EON MINI 16-CHANNEL IPG

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 9, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 13, 2014

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

    RESTYLANE

    FDA Adverse Event
    Injury ·Q-MED·Product code LMH·December 12, 2023

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 20, 2018

    Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·November 6, 2019

    Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·November 6, 2019

    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