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

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    MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM

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

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450217757·

    TMW

    FDA UDI
    HERAEUS MEDICAL COMPONENTS, LLC·00816840020401·

    MODIFICATION TO SOLO

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)

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

    ACCUTORR PLUS II MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014

    E360 VENTILATOR

    FDA Adverse Event
    Other ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 6, 2011

    AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

    FDA Enforcement
    Class II ·Terminated·Cayenne Medical Inc.·August 1, 2018

    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