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

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    Dental LT Clear V2 Resin

    FDA 510(k)
    FDA Unclassified ·Unknown

    HEALIX TI 3 SUTURE ANCHOR w/DYNACORD

    FDA UDI
    Medos International Sàrl·10886705029983·HEALIX TI 3 SUTURE ANCHOR w/DYNACORD Titanium A...

    Bernafon

    FDA UDI
    Bernafon AG·05714464008926·BERNAFON ALPHA 9 MNR T R SABE/MAC

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112540·BARRON VACUUM TREPHINE 8.75MM

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044204636·TEST TUBE 13X100MM 2-POS CAP

    Pinnacle

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730010018·Pinnacle 022 MC(0T) U/L 5x5 Hks 3 SPK, OS Pad U...

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730008183·Votion 022 MC(0T) U/L 5x5 Hks 3, OS Pad U/L 4/5...

    Pinnacle®

    FDA UDI
    Ortho Organizers, Inc.·00190707111960·Pinnacle .022 MC(0T) U/L 5x5 Hks 3 SPK, OS Pad ...

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707113872·Votion .022 MC(0T) U/L 5x5 Hks 3, OS Pad U/L 4/...

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 2, 2024

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 2, 2024

    K-Y BRAND LIQUIBEADS

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

    CVSI PERIPHERAL BALLOON CATHETER; CVSI INFLATER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 3, 2024

    CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING WITH DURAFLO TREATMENT

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·November 3, 2008

    APEX BALLOON CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·August 24, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 1, 2013

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014