BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    WOLF Thrombectomy System, 14F

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ionosit Baseliner

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2109111·Light-curing compomer base liner. Gap-free rest...

    Zavation

    FDA UDI
    Zavation LLC·00842166132559·Ti3Z CIF 13mmx15mmx11mm -9 deg

    ZAVATION

    FDA UDI
    Zavation LLC·00842166104648·CIF 13x15, 9 deg, -11

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167322109110·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167312109110·

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046508244·Rotary FG gold diamond instrument for dental ap...

    MDT Diamond Coated Dental Burs

    FDA UDI
    M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046508237·Rotary FG gold diamond instrument for dental ap...

    MACROPORE OS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RENAISSANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·November 22, 2019

    INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code HSB·March 1, 2016

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    AVANCE

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·November 9, 2015

    Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

    FDA Enforcement
    Class I ·Ongoing·Whele LLC DBA Perch·November 30, 2022

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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