BEUDAMED
    11 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 ×

    ERBE VIO APC WITH ACCESSORIES

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

    OneTouch Ultra2 Blood Glucose Monitoring System.

    FDA UDI
    LifeScan Europe GmbH·00353885011860·OneTouch Ultra2 Blood Glucose Monitoring System.

    APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE

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

    HOME-AWAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UNICEL® DXC 660I SYNCHRON® ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·March 27, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·March 11, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·April 5, 2008

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·September 25, 2018

    Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 28, 2018

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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