BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    CHOLINESTERASE GEN.2 TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    RealStar® ASR HSV-2 Probe

    FDA UDI
    altona Diagnostics GmbH·04250453100956·Herpes simplex virus 2 (HSV-2) DNA specific pro...

    RealStar® ASR HSV-2 Primer

    FDA UDI
    altona Diagnostics GmbH·04250453100949·Herpes simplex virus 2 (HSV-2) DNA specific primer

    RealStar® ASR HSV-1 Probe

    FDA UDI
    altona Diagnostics GmbH·04250453100932·Herpes simplex virus 1 (HSV-1) DNA specific pro...

    RealStar® ASR HSV-1 Primer

    FDA UDI
    altona Diagnostics GmbH·04250453100925·Herpes simplex virus 1 (HSV-1) DNA specific primer

    AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANDELA SPTL-1B PULSED DYE LASER

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

    VIASYS

    FDA Adverse Event
    Malfunction ·CAREFUSION 207, INC·Product code CBK·October 26, 2009

    E500 VENTILATOR SYSTEM

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS, INC·Product code CBK·July 11, 2016

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 16, 2013

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·April 18, 2011

    PRECISION XTRA /OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·June 13, 2008

    Z NAIL CMF 13MMX17.5CM 130L

    FDA Adverse Event
    Malfunction ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·November 11, 2021

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC·Product code CBK·October 27, 2009

    VIASYS

    FDA Adverse Event
    Other ·CAREFUSION 207, INC.·Product code CBK·October 27, 2009

    Z NAIL CMF 10.5 X 100 LAG SCR

    FDA Adverse Event
    Malfunction ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·November 11, 2021

    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

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    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