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

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    DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Azur

    FDA UDI
    PURELIFE, LLC·D79010617031·Azur Nitrile Powder-Free, Medium, Ultra-soft ni...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040109240·INTRAORAL AMBER ELASTICS 3/8" 6 OZ X-HEAVY

    REAMER SHAFT, AO FITTING ?8,0X448 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 7, 2011

    PERCLOSE VASCULAR SUTURE DELIVERY DEVICE

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

    LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES

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

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 28, 2014

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·April 19, 2013

    INTERLOCK¿-35

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRD·April 16, 2013

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·September 4, 2014

    ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 18, 2011

    Integrated Orbiter Single Detector General Purpose Gamma Camera System; Siemens Medical Systems, Inc., Nuclear Medicine Group, 2501 North Barrington Road, Hoffman Estates, IL 60195-5203

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYX·February 10, 2003

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015