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

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    ENGSTROM CARESTATION, ENGSTROM PRO

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDEX

    FDA Adverse Event
    Malfunction ·Product code FRN·May 14, 2020

    AVERA MODEL DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    PALOMAR SPALIGHT PULSED LIGHT SYSTEM

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

    MEDACTA KNEE IMPLANTS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 6, 2013

    TIBIAL ALIGNMENT ANKLE CLAMP EM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·September 16, 2014

    LIGHTSPEED VCT

    FDA Adverse Event
    Other ·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011

    SORIN AF 620 W/LOOP 10

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWE·June 25, 2010

    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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018