BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    N LATEX B2-MICROGLOBULIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·September 8, 2021

    Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·July 22, 2021

    BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·February 11, 2013

    BECKER TEARDROP 4MM 26CM LG

    FDA Adverse Event
    MENTOR WORLDWIDE LLC·Product code MUU·July 16, 2014

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013