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

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    P.R.G. GUIDEWIRE PLACEMENT SYSTEM

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

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517176509·VuePoint Cross Connector, 3x36mm Rod

    ALLOFUSE PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·November 15, 2017

    RELOADABLE LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 30, 2014

    TRIAGE CARDIAC PANEL 25 TEST

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code MMI·November 12, 2010

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 30, 2012

    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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024