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

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    MODIFIED DECANNULATION STOPPER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994238726·ROD 7894050 STRAIGHT 5.5MM X 50MM PEEK

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867051638·LOW PROFILE SCREW, TI, 4.0MM X 50MM

    TRABECULAR METAL™

    FDA UDI
    ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024306769·

    TRABECULAR METAL™

    FDA UDI
    ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024306783·

    TRABECULAR METAL™

    FDA UDI
    ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024306790·

    TRABECULAR METAL™

    FDA UDI
    ZIMMER TRABECULAR METAL TECHNOLOGY INC.·00889024306776·

    ITOTAL CR KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROTOPATH FACTOR IX ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    SPEEDBAND SUPERVIEW SUPER 7?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FHN·June 25, 2014

    PINNACLE MTL INS NEUT36IDX54OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·January 3, 2013

    LIFEVEST WCD 3100 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 4, 2010

    IMPELLA 5.5

    FDA Adverse Event
    Injury ·ABIOMED, INC.·Product code OZD·November 17, 2025

    XLPE 10 DEG POLY LINER 58X36

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·August 12, 2025

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·October 24, 2024

    AVANTAGE CEMENTED ACETABULAR CUP SIZE 48

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code KWZ·August 17, 2020

    NOVATION HIP COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code LPH·July 23, 2025

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

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

    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