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

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    INTEGO Family and Accesories

    FDA 510(k)
    FDA Class 1 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131282729·RIA2 PRO, BTE 13 WL 100 SGR

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100035·BARRAQUER HEAVY WIRE SPECULUM LARGE

    REPROCESSED COMPRESSION SLEEVES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL..

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYRINGE 10ML LL S/C 200

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 16, 2019

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES GRENCHEN·Product code HRS·January 30, 2017

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 6, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008

    AUGMENTED INSERT

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code KWA·June 29, 2011

    MISAGO RX Self Expanding Peripheral Stem

    FDA Enforcement
    Class II ·Terminated·Terumo Medical Corp·December 7, 2016

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 19, 2023

    VERSACROSS ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DYB·April 20, 2023

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023

    Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W; Immutest 7 panel, Item No. IMCA-7P; ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015