BEUDAMED
    25 results · 27ms · 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 ×

    LIGHT CURE RETAINER

    FDA 510(k)
    FDA Class 2 ·Dental

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691011·

    PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EZ SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    XACT CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIM·January 14, 2011

    ACCELSTIM

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code LOF·June 5, 2023

    OLYMPUS SINGLE USE LEGATING DEVICE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·April 22, 2013

    ALARIS EXTENSION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·May 18, 2011

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    FDA Adverse Event
    Malfunction ·CORDIS NEUROVASCULAR, INC.·Product code HCG·August 6, 2008

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·January 6, 2020

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·February 18, 2020

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·COMPRESSION THERAPY CONCEPTS, INC.·Product code JOW·September 17, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·November 19, 2019

    VASOPRESS DIGITAL MINI PUMP

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code JOW·December 10, 2019

    MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·February 19, 2014

    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 27, 2013

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Model Number L101, ESSENTIO DR SL Pacemaker

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

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021