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

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    NITI-S BILIARY STENT

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

    BCC GAMMA CAMERA

    FDA 510(k)
    FDA Class 2 ·Radiology

    REVEAL PLUS INSERTABLE LOOP RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 24, 2015

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 24, 2015

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·November 24, 2015

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWA·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. HOMECARE PRODUCT, INC·Product code INI·April 23, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 13, 2011

    COAXIAL MICRO-PUNCTURE INTRODUCER SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·July 9, 2008

    BIOLOX OPTION, HEAD, S, 44/-3.0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·December 12, 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

    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