BEUDAMED
    14 results · 34ms · Sources: EU EUDAMED, US FDA

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    Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250298030·ceraMotion® Paste 3D Incisal opal bright / dent...

    METER C - OT PROFILE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·December 6, 2001

    Entropy Module, E-ENTROPY-01

    FDA 510(k)
    FDA Class 2 ·Neurology

    IPACS PRISM-5.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 13, 2022

    MPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·July 11, 2023

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code OYC·June 24, 2019

    SENSOR ENLITE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·May 14, 2015

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 6, 2014

    SPECTRANETICS LEAD LOCKING DEVICE

    FDA Adverse Event
    Injury ·SPECTRANETICS CORPORATION·Product code DRB·July 26, 2013

    UNKNOWN ZIMMER NAIL

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code HAO·November 25, 2015

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    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