BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    SPIROVIT, MODEL SP-250

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984031·anteriors; shade A1; mould 91

    P.F.C.

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295252290·P.F.C. TIBIAL INSERT FIXED BEARING CURVED 1 10m...

    Trinias

    FDA UDI
    SHIMADZU CORPORATION·04540217058792·

    FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT

    FDA 510(k)
    FDA Class 1 ·Hematology

    PHARMASEAL GENETIC AMNIOCENTESIS TRAY

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    VECTRA GRAFT, 6MM W/GRAD REINFORCE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·November 8, 2017

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·February 28, 2013

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·February 10, 2011

    BLACKMAX-NEURO

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBB·December 18, 2013

    Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 1, 10.0 mm; Ref 98-4031.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code JWH·May 26, 2005

    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