BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    APF POROUS COATED LINE EXTENSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Polystar HK

    FDA UDI
    Merz Dental GmbH·D7091984154·anteriors; shade A3.5; mould R 76

    P.F.C.

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295252443·P.F.C. TIBIAL INSERT FIXED BEARING CURVED 4 12....

    METABOLIC SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRANSLUMINAL ENDARTERECTOMY DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    REALIZE ADJ GASTRIC BAND STR

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·February 10, 2011

    SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 4 MM TIP UNIVERSAL TEMPERATURE MONITORI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.·Product code LPB·September 28, 2016

    8CM ANGLE ATTACHMENT

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

    Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4154.

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

    Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX

    FDA Enforcement
    Class I ·Ongoing·Baxter Healthcare Corporation·March 12, 2025

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024