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

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    GAMBRO AK-10-UDM-10-A ULTRADIFFUSION

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

    MGB Alert HHV-6 Probe Mix ASR - 48 rxn

    FDA UDI
    Elitechgroup Mdx LLC·03661540951565·"MGB Alert® HHV-6 Probe Mix is an analyte speci...

    ACUMED

    FDA UDI
    Acumed LLC·10806378042089·LE Modular System Base and Lid Assy

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306810275·Rubinstein Diamond, 13G x 15cm, Straight, Luer,...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306835629·Pre-Assembled Rubinstein Diamond, 13G x 15cm, S...

    CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ISOBAR SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 8, 2014

    LIFEPAK(R) 1000 DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·October 22, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007

    Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code LRO·January 9, 2017

    Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021