BEUDAMED
    22 results · 24ms · Sources: EU EUDAMED, US FDA

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    TENSCARE ITOUCH SURE MODEL ITS

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

    ALTERNATE BEARING HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304237445·

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Injury ·ALERE SCARBOROUGH, INC.·Product code MZF·May 28, 2019

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ALERE SCARBOROUGH, INC.·Product code MZF·May 28, 2019

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code MZF·July 12, 2019

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ALERE SCARBOROUGH, INC.·Product code MZF·May 28, 2019

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ALERE SCARBOROUGH, INC.·Product code MZF·May 28, 2019

    AST (SGOT)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STCC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code MZF·June 26, 2019

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·May 23, 2011

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Injury ·SURGIQUEST, INC.·Product code GCJ·September 25, 2014

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Injury ·SURGIQUEST, INC.·Product code GCJ·March 11, 2015

    SURGIQUEST AIRSEAL

    FDA Adverse Event
    Other ·SURGIQUEST, INC.·Product code HIF·December 12, 2013

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021