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

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    MODIFICATION TO: POCKETVIEW ECG SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0130110·Segmental Rod Reducer, Slim, Assembly

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024069·Paddle Shaver, 11mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103110·Shaver, Closed, 11mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0132110·Trial, TLIF, 27L OB CRV 7Deg, 11mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134110·Trial, TLIF, 27L OB STR 7Deg, 11mm

    Alleset

    FDA UDI
    GRI Medical & Electronic Technology Co., Ltd.·16931918171333·Back Table cover_112cmx112cm_1040ea/cs

    NUTRISAFE PUR ENTERAL FEEDING TUBE

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

    LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE

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

    STATIC/DYNAMIC SHEATH

    FDA Adverse Event
    Injury ·BIOMET·Product code LXH·August 17, 2012

    COMPRESSION TARGETING DEVICE

    FDA Adverse Event
    Injury ·BIOMET·Product code LXH·August 17, 2012

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 20, 2013

    CRYOVALVE PULMONARY VALVE & CONDUIT

    FDA Adverse Event
    Injury ·CRYOLIFE, INC.·Product code MIE·March 10, 2011

    EXACTA-MIX 600 UNIVERSAL PUMP

    FDA Adverse Event
    Other ·BAXA CORP.·Product code LHI·March 14, 2008

    OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    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