BEUDAMED
    12 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    BUFF. FILTER REPLACEMENT FILTER #BST312CO,BST306CO

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

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515236660·Ballenger Chisel, V-shaped edge, 2mm wide

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939204·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955936869·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938030·Percutaneous Transluminal Angioplasty Balloon C...

    SPINEMED

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Light Based Hair Removal Device GP592

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

    3002

    FDA Adverse Event
    Malfunction ·STRYKER·Product code FNL·January 24, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 2, 2010

    LIBERTY CYCLER SET

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·March 10, 2014

    PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS CR MOB PLT SZ 5 L¿ PRCT MIS CR MOB PLT SZ 6 L¿ PRCT MIS CR MOB PLT SZ 7 L¿ PRCT MIS CR MOB PLT SZ 7 R¿ PRCT MIS CR MOB PLT SZ 8 L¿ PRCT MIS CR MOB PLT SZ 8 R This device is indicated for patients with severe knee pain and disability¿

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR-Flex porous coated femoral components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral components may only be used uncemented. All other femoral and tibial baseplate components are indicated for cemented use only. " CR-Flex Mobile articular surfaces are intended for use with a functional posterior cruciate ligament (PCL). UC-Flex Mobile articular surfaces are intended for use with an absent or deficient PCL. " Specific uses with CR-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with CR-Flex Mobile or UC-Flex Mobile articular surfaces, is intended for use when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016