BEUDAMED
    8 results · 21ms · 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 ×

    JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300

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

    ACTICHROME HEPARIN (ANTI-FIIA)

    FDA 510(k)
    FDA Class 2 ·Hematology

    TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 6, 2013

    3.5MM LCP LOW BEND MEDIAL DSTL TIBIA PLATE/10H/LEFT/187MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·September 16, 2014

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·April 6, 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

    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