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

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    FETAL MONITORING SPIRAL ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Mini Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746063565·DB BKT MINI MS LL CUSP 022 T+7 A+5 R=0

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746100666·DB BRACKET MASTER SERIES MAND LEFT CUSPID 022 T...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707066187·LIGATURE WIRE 012" reel

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221112835·3M™ Victory Series™ Second Molar Bands, 905-130...

    BLOOD GROUPING REAGENT ANTI-D BLEND

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·September 18, 2019

    MODIFIED SEISMOCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENTERA-FLO FEEDING TUBE

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

    BLOOD GROUPING REAGENT ANTI-D BLEND

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·October 23, 2019

    BLOOD GROUPING REAGENT ANTI-D BLEND

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code QHR·January 9, 2020

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·May 29, 2014

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013

    ECHELON 60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 22, 2010

    BLOOD GROUPING REAGENT ANTI-D BLEND

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code KSZ·September 2, 2019

    Mitek Screw and Washer Depth Gauge, Product Code 219024

    FDA Enforcement
    Class II ·Terminated·DePuy Mitek, Inc., a Johnson & Johnson Co.·October 31, 2018

    various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10 Degree Face Changing E1 Liner RingLoc Bi-Polar Ringloc Hi-Wall ArCom Liner RingLoc Hi-Wall ArComXL Liner RingLoc Hi-Wall E1 Liner Ringloc Neutral Max-Rom ArCom Liner RingLoc Neutral Max-Rom ArComXL Liner RingLoc Neutral Max-Rom E1 Liner Product Usage: For use in hip arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024