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

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    CHOCOLATE AGAR W/ENRICHMENTS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    NAR Kit

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209108602·KIT, MINI MEDIC - BASIC - ODG

    EAR THERMOMETER, MODELS ST66 AND ST67

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX

    FDA 510(k)
    FDA Class 2 ·Dental

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·May 8, 2014

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·October 18, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007

    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.

    FDA Recall
    Terminated ·Derma Pen, LLC·Product code PIU·February 5, 2015

    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by persons up to 95 pounds for transport.

    FDA Recall
    Terminated ·Ki Mobility Llc·Product code INM·November 19, 2021

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021