BEUDAMED
    8 results · 21ms · 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.
    Filters Regulation: Us FDA ×

    SYNERGY SPINAL SYSTEM (6.35 POLARIS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HIVOX DREAMATE DM-800

    FDA 510(k)
    FDA Class 2 ·Neurology

    DRUGS OF ABUSE MULTI-TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    2.0MM DRILL BIT WITH 12MM STOPQC

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code OVE·April 29, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 5, 2011

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 23, 2008

    DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)

    FDA Enforcement
    Class I ·Terminated·Synthes, Inc.·August 27, 2014

    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