BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VKMO 70000 #QUAD-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VEMO 7000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827899·ACHIMED ACHILLES SUPP BLACK I

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827837·***DISC*LEVAMED ANKLE SUPPORT BLACK I

    Buccal Tubes

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746083587·DB TUBE INCONEL LOWER MOL 022 T=0 R=0 2MM

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036030087·

    MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 17, 2025

    ADULT DUAL HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 15, 2009

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·April 19, 2011

    TENDRIL ST

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 2, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 15, 2014

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024