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

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    NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169342330·INTRDSCL DRIL GUIDE 3031060

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0380600·Egg Handle, Threaded, 1.5"

    FRESENIUS ICARE MONITORING SYSTEM

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

    ICS MEDICAL MODEL VG-30 VIDEO GOGGLES

    FDA 510(k)
    FDA Class 2 ·Neurology

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·March 28, 2013

    PERMACOL 20X30 1.5MM

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·March 16, 2011

    30327 12CC 100 UNIT HEP SYR {CAN} (5CC)

    FDA Adverse Event
    Malfunction ·TYCO HEALTHCARE/KENDALL·Product code NZW·April 15, 2008

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020