BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    UNIMIDE

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

    VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WH ACCU TEST PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CPT PETITE FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JDI·August 31, 2016

    OXIMAX N-560 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·NELLCOR PRITAN BENNETT·Product code DQA·April 3, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 6, 2011

    CONTAK RENEWAL 3 RF

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·October 15, 2014

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

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

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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