BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    Radiance V4

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDTRONIC C315 DELIVERY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANTIMICROBIAL AND SINGLE-PATIENT CUFFS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    FDA Adverse Event
    Injury ·CORCYM CANADA CORP.·Product code LWR·August 4, 2021

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 25, 2019

    SYRINGE 3ML LL 200 S/C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 7, 2019

    3 ML BD LUER-LOK LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·October 4, 2019

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 27, 2020

    LF NITRO PUMP SET W/LIGHT PROTECTIVE TUB

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·June 7, 2013

    ARCHITECT I2000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·July 22, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014

    NIBP CUFFS

    FDA Adverse Event
    Injury ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code OED·August 8, 2025

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021