BEUDAMED
    21 results · 20ms · Sources: EU EUDAMED, US FDA

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    LANO-E

    FDA 510(k)
    FDA Class 1 ·General Hospital

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694002363·1.6mm x 4mm AUTO-DRIVE Screw

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434557·Tasso+ convenience kit allows self-collection o...

    MicroSelectron Digital

    FDA UDI
    Nucletron B.V.·08717213026117·microSelectron Transfer Tube for 4F Flexibles (22)

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383504126·Gutta Percha Points is used to root canal filin...

    1.6MM X 4MM AUTO-DRIVE SCREW

    FDA Adverse Event
    Malfunction ·OSTEOMED, LLC·Product code HWC·October 20, 2022

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694031011·1.6mm x 4mm Auto-Drive Screw, Sterile

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694044004·1.6mm x 4mm AUTO-DRIVE Screw

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694054508·1.6mm x 4mm Auto-Drive Screw Sterile Qty 10

    VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ascendant

    FDA UDI
    Choice Spine, LP·10885862260765·

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·May 6, 2013

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·June 2, 2011

    MICROMAX SYSTEM CUTTERS

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·August 12, 2008

    OSTEOMATCH

    FDA Adverse Event
    Injury ·MEDCAD·Product code GXN·December 1, 2017

    LOCKSCR Ø3.5 SELF-TAP L60 SST

    FDA Adverse Event
    Injury ·SYNTHES GRENCHEN·Product code JDS·September 25, 2017

    Synchron LX Clinical Systems Software

    FDA Recall
    Terminated ·Beckman Coulter Inc·October 7, 2003

    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System components include Gas-cooled Laser Delivery Probes to deliver controlled energy to a target zone.

    FDA Enforcement
    Class II ·Terminated·Monteris Medical Corp·November 26, 2014

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021