BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    INRATIO SELF-TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 1, 2011

    Safco FG Diamonds

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310219233·FG Diamond 379-023 football regular 5/pack

    REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201

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

    COROX OTW-L 85-BP

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NKE·March 26, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 25, 2011

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIV·Product code FNL·March 28, 2008

    ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIU·June 2, 2021

    BACT/ALERT I NST 100 BTLS - 259785

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX INC.·Product code MDB·March 4, 2024

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

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

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017