BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    DOPPLER FETAL HEARTBEAT RATE DETECTOR

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

    BREATHING BAG

    FDA UDI
    King Systems Corporation·00612649185736·BAG,1/2 LITER LATEX FREE

    Buccal Tubes

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746083556·DB TUBE INCONEL LOWER MOL 018 T=0 R=0 2MM

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345027237·Inserter, 7-10MM, Lumbar Straight

    ART-M1, MODEL M1-1-ART-A1

    FDA 510(k)
    FDA Class 2 ·Dental

    BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1

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

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

    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

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    BE-VEMO 7000 #QUADR-I HMO70000+VHK7100

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

    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
    Injury ·MEDTRONIC MINIMED·Product code OYC·September 15, 2014

    HEART START XL

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

    CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015

    ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CEM·January 12, 2011

    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