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

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    Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540538451·ADAPTER FROM STRYKER TO HEX SHAFT

    Bradshaw Medical Inc.

    FDA UDI
    Bradshaw Medical, Inc.·00810019930836·BIT, HEX MALE 4.5MM 1/4 SQ

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117476·Distal Reamer (Hudson)

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192695·Distal Reamer (Hudson)

    Monkey Rings™ External Fixation System

    FDA UDI
    Paragon 28, Inc.·00889795116352·Rancho Cube, Ø5.0 Centering Collar

    NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Klassic Knee System-Sombrero Patella

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 14, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 15, 2011

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019