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

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    INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BREEZE SELF-ADHESIVE RESIN CEMENT

    FDA Adverse Event
    Injury ·PENTRON CLINICAL·Product code EMA·May 29, 2013

    SSA-770A, APLIO ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DW 277 #4

    FDA 510(k)
    FDA Class 2 ·Dental

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code HQL·May 1, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE ? SINGAPORE·Product code FKX·September 16, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 12, 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