BEUDAMED
    16 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 ×

    MEDNEXT SURGICAL BUR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    artegral

    FDA UDI
    Merz Dental GmbH·D7091970023·anteriors; shade A1; mould UBL

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690119753·TIBIAL BASEPLATE/INSERT IMPACTOR

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89700231·Mand. 2. Molar band W-Fit right 23

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697421·PAI Dental Implant Ø6mm L8mm

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89700230051·Mand. 2. Molar band W-Fit right 23

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89700230101·Mand. 2. Molar band W-Fit right 23

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR89700230501·Mand. 2. Molar band W-Fit right 23

    SPiN Thoracic Navigation System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICROSURGEON MICROWAVE TISSUE ABLATION DEVICE, MODEL MTAD-100

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

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024158900·

    ZMR®

    FDA UDI
    Zimmer, Inc.·00889024158894·

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·April 28, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 20, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·January 14, 2011

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017