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

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    RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector

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

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003272·Diagnostic EP Catheter, Josephson curve, 4 elec...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694016117·Cheek Retractor, Clamp

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180102965·RF MONOPOLAR CABLE WITH MALE LUER LOCK INSTRUME...

    SafeOp

    FDA UDI
    ALPHATEC SPINE, INC.·00190376189154·Right stimulator cable

    YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA

    FDA 510(k)
    FDA Class 1 ·Dental

    APPLIED URETERAL CATHETER

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

    NOVALIS

    FDA Adverse Event
    Other ·BRAINLAB AG·Product code IYE·April 7, 2005

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 24, 2014

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITJ·July 1, 2013

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·April 3, 2019

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021