BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEPUY SUMMIT TAPERED HIP STEM WITH POROCOAT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS·Product code LWJ·March 1, 2013

    SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 19, 2024

    POLYFORM SYNTHETIC MESH

    FDA Adverse Event
    Injury ·PROXY BIOMEDICAL LTD.·Product code FTL·April 23, 2013

    SUPERDIMENSION INREACH SYS

    FDA Adverse Event
    Injury ·SUPERDIMENSION INC.·Product code JAK·September 4, 2014

    INSTA TRAK 3500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code LLZ·May 2, 2011

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015