BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    TRANSOM ANTERIOR CERVICAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16741420600·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B1674142060060·

    VascuTrak®

    FDA UDI
    Bard Peripheral Vascular, Inc.·00801741061103·VascuTrak® PTA Dilatation Catheter 2 mm x 60 mm...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X1420600·14mm H x 20mm W x 60mm L x 0 degrees XLIF

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111047473·OP SCISS 6" CVD SH/BL

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587L142060120·14mm H x 20mm W x 60mm L XLIF Trial 12 degree L...

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X142060120·14mm H x 20mm W x 60mm L x 12 degrees XLIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587X14206080·14mm H x 20mm W x 60mm L x 8 degrees XLIF

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 27, 2022

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 27, 2022

    EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RADIANCE

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    RESERVOIR 1.8ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 4, 2014

    SCULPTRA, POLY-L-LACTIC ACID

    FDA Adverse Event
    VALEANT USA·Product code LMH·May 29, 2013

    CAPIO SUTURE DEK BL MF 48"

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code MFJ·May 24, 2011

    AERO LL FIXATION ANCHOR, 50MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code OVD·March 25, 2019

    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021