BEUDAMED
    15 results · 29ms · Sources: EU EUDAMED, US FDA

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    ISAAC Neurovascular Navigation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GLOBAL PROTECTION CORP.

    FDA registration
    GLOBAL PROTECTION CORP.·7 products·🇺🇸 United States

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707098119·EXACONNECT PLUS 2.2 ANG. 15° GH1,5

    CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLAGEN DENTAL WOUND DRESSINGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    CAPIOX HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 3, 2024

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·November 5, 2008

    CRE(TM) BALLOON DILATATION CATHETER

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code KOG·August 24, 2011

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 2, 2013

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024

    Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·July 8, 2015

    Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :115-150, 115-167, 115-185, 115-203, 115-222, 115-253, 115-272, 115-290, 115-322, 115-354, 115-378, 115-401, 115-435, 115-469, 115-507, 115-547, 115-586, 115-627, 115-666, 115-716; Style 120: 120-180, 120-220, 120-260, 120-300, 120-340, 120-400, 120-440, 120-500, 120-550, 120-600, 120-650; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

    FDA Enforcement
    Class I ·Ongoing·Allergan PLC·September 18, 2019

    Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-270, 110-300, 110-330, 110-360, 110-390, 110-420, 110-450, 110-480, 110-510; Style 115 :115-150, 115-167, 115-185, 115-203, 115-222, 115-253, 115-272, 115-290, 115-322, 115-354, 115-378, 115-401, 115-435, 115-469, 115-507, 115-547, 115-586, 115-627, 115-666, 115-716; Style 120: 120-180, 120-220, 120-260, 120-300, 120-340, 120-400, 120-440, 120-500, 120-550, 120-600, 120-650; These products may have been sold under the McGhan, Inamed or NATRELLE brands. Product Usage: Breast augmentation and Breast reconstruction

    FDA Recall
    Open, Classified ·Allergan PLC·Product code FTR·July 24, 2019