BEUDAMED
    7 results · 19ms · 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.
    Filters Regulation: Us FDA ×

    STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU

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

    ZINETICS INTERNAL REFERENCE PROBE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    CUSTOMED ANGIODRAPE PACK FEMORAL

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

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 13, 2015

    3.5MM CORTEX SCREW SELF-TAPPING 14MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·January 14, 2013

    SYSTEM 6 SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·July 3, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015