BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    BLUE SKY BIO DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743595·LEVAMED ANKLE SUPPORT SAND II

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964152542·Endo Carry-on Procedure Kit contains Basin, VIA...

    DATEX-OHMEDA CS/3 TELEMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BABY DOPPLEX 4002-TWINS, MODEL BD4002

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    STREP A RAPID TEST STRIP (THROAT SWAB)

    FDA Adverse Event
    Death ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code GTY·March 25, 2024

    ASR ACETABULAR IMPLANT 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 19, 2013

    PLUM SET

    FDA Adverse Event
    Malfunction ·HOSPIRA·Product code FPA·February 18, 2011

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL AB·Product code DTB·March 10, 2008

    Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for easy size identification. Bony fixation is achieved using two (2) tibial screws, two (2) calcaneal screws and one (optional) talar screw. The nail, cross-locking screws and end cap are manufactured from a titanium alloy: TI-6AI-4V ELI ISO 5832-3, ASTM F136. The PANTA Arthrodesis Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. The Panta Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: " Post-traumatic and degenerative arthritis involving both ankle and subtalar joints. " Rheumatoid arthritis. " Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body. " Revision of failed total ankle arthroplasty with subtalar intrusion. " Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis). " Avascular necrosis of the talus. " Neuroarthropathy or neuropathic ankle deformity. " Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease. " Severe pilon fractures with trauma to the subtalar joint.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code HSB·May 19, 2011

    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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012