BEUDAMED
    77 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.

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

    NA

    FDA UDI
    Stryker GmbH·00886385005218·Cortical Screw, Self-tap., T6 Drive

    Phantom® Fibula Nail System

    FDA UDI
    Paragon 28, Inc.·00889795133915·2.7mm x 18mm, Threaded Peg, Ti

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033450482·

    FLEXI-SITE SP02 EAR SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 22, 2006

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 22, 2006

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 22, 2006

    GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and volume.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·December 12, 2018

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 22, 2006

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 22, 2013

    UNKNOWN DEPUY ASR RESURFACING HEAD

    FDA Adverse Event
    Injury ·DEPUY INTL LTD·Product code KWA·February 24, 2011

    BD PARADIGM LINK GLUCOSE MONITOR

    FDA Adverse Event
    Malfunction ·NOVA BIOMEDICAL CORPORATION·Product code NBW·March 11, 2008

    TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor Product Number: 72202608

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·October 28, 2020

    POSTERIOR PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·April 12, 2021

    POSTERIOR PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·December 29, 2021

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·June 1, 2021

    ANTERIOR PELVIC FLOOR REPAIR S

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·November 18, 2021