BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    SYSTEM 12 CONSTRAINED ACETABULAR LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Alice 6

    FDA UDI
    Respironics, Inc.·00606959020740·Alice 6 LDE Headbox, International

    TI-DBLE LEAD CORT SCR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSB·August 24, 2018

    CLIRANS E-SERIES DIALYZER

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

    INFINITY ETCO2 + RESPIRATORY MECHANICS POD

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 12, 2013

    60MM STRAIGHT ENDOSCOPIC LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·POWER MEDICAL INTERVENTIONS·Product code GDW·June 19, 2008

    CAPSURE EPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·April 19, 2011

    Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 180 mm, Item Number: 814313180

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 19, 2018

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015