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

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    ACS APCT REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690130024·Retaining Bolt, PS or PS-C Insert, Revision Tib...

    FORA COMFORTSCAN EAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570

    FDA 510(k)
    FDA Class 2 ·Neurology

    E1 RINGLOC BIPOLAR 28X51MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LZO·June 17, 2019

    BIOMEX SHELL PC DIA48MM LN 22

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LZO·December 2, 2015

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·January 17, 2013

    BRONCHOSCOPE

    FDA Adverse Event
    Other ·OLYMPUS·Product code EOQ·December 8, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 9, 2014

    Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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