BEUDAMED
    10 results · 26ms · Sources: EU EUDAMED, US FDA

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    RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS

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

    Harvard PremiumFlow A1

    FDA UDI
    Harvard Dental International GmbH·EHAR70822111·Flowable light cure nano-hybrid composite for r...

    EFILM WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2013

    ECHELON*FLEX60 LONG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2011

    ACCU-CHEK ULTRAFLEX INFUSION SET

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code FPA·July 25, 2008

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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