BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    Introducer Sheath Kits

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLASH-LITE LED DENTAL CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    ECG CHECK

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·March 1, 2000

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2014

    OXFORD UNICOMPARTMENTAL KNEE PHASE 3 ANATOMIC MENISCAL BEARING LARGE SZ 8

    FDA Adverse Event
    Injury ·BIOMET UK LTD·Product code NRA·August 24, 2011

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNS·July 3, 2013

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024