BEUDAMED
    24 results · 24ms · Sources: EU EUDAMED, US FDA

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    Dayspring Lite

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113240·VITRECTOMY KNIFE 23GA (BX/5)

    Deltec

    FDA UDI
    ICU MEDICAL, INC.·00610586024088·

    MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Ran-Flex-B Bone Marrow Aspiration Needle

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

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code KPE·August 15, 2011

    GYNECARE PROLIFT POSTERIOR PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 9, 2013

    PORT-A-CATH PLASTIC HUB BENT NEEDLE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, INC.·Product code LJT·September 21, 2015

    PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with standard luer lock connectors.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code LJT·September 14, 2015

    PORT-A-CATH® PLASTIC HUB BENT NEEDLE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL·Product code LJT·September 21, 2015

    PORT-A-CATH® PLASTIC HUB BENT NEEDLE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL·Product code LJT·September 21, 2015

    PORT-A-CATH PLASTIC HUB BENT NEEDLE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, INC.·Product code LJT·September 21, 2015

    PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with standard luer lock connectors.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·October 28, 2015

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·June 5, 2019

    ACCESS 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 10, 2011

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 3, 2012

    2122870-2017-00017

    FDA Adverse Event
    Malfunction ·February 24, 2017

    2122870-2015-00862

    FDA Adverse Event
    Malfunction ·December 16, 2015

    Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025