BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50

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

    ADVIA Centaur® ACS:180® Calibrator U

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414178493·Myoglobin - CENTAUR - CAL - 2x2x2mL

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213015661·microSelectron Transfer Tube for 4F Flexibles (11)

    BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·January 24, 2022

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08809282819957·

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08809282819940·

    ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DSS STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390869461·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390869478·

    BD PLASTIPAK¿ SYRINGES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 16, 2022

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·April 8, 2021

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·May 14, 2013

    VECTORVISION NAVIGATION SW SPINE

    FDA Adverse Event
    Other ·BRAINLAB AG·Product code HAW·May 23, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 24, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·August 17, 2022

    BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·December 29, 2020

    The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·June 12, 2013

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024