BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    VARIAX DISTAL FIBULA PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code DHA·May 8, 2014

    REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code MAX·October 17, 2012

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2010

    Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·September 30, 2015

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    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