BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    HEMOSIL FACTOR V DEFICIENT PLASMA

    FDA 510(k)
    FDA Class 2 ·Hematology

    CENTRAL VENOUS CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIO-RAD PLATELIA TOXO IGG TMB

    FDA 510(k)
    FDA Class 2 ·Microbiology

    28MM -4 V40 TAPER VIT HEAD

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LWJ·March 27, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 14, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 2, 2008

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 12, 2011

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 12, 2011

    HOSP SS FLEXX METER LASER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 17, 2011

    HOSP SS FLEXX METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·May 12, 2011

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016