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

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    EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776116118·Pass Thru Bracket

    SEASPINE SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VAP-NT CHOLESTEROL TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INFUSE BONE GRAFT 12 MG

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code NEK·May 1, 2014

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 10, 2014

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 14, 2011

    HAMILTON-G5

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 16, 2026

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSD·January 9, 2024

    EQUINOXE PRESERVE STEM 12MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·May 29, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·April 6, 2022

    EQUINOXE REVERSE 46MM GLENOSPHERE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·October 2, 2024

    Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 29, 2025

    Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical AG·June 24, 2026

    BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, Catalog # 10013902 BD EXTENSION SET TRI-PORT SMALLBORE TUBING CHECK VALVE 3 SmartSite" VALVES, Catalog # 20062E; BD SECONDARY SET VENTED NONVENTED 20 DROP W/ 2 HANGERS, Catalog # 70000N-07; BD MaxGuardTM tri-fuse extension set, Catalog # ME1224; BD 20-IN EXTENSION SET W/ 0.2 MICRON FILTER ONE SmartSiteTM VALVE AND TexiumTM, Catalog # 20350ET; BD 31-IN SEC SET 20DP W/BAG ACCESS PORT TexiumTM AND HANGER LOW SORBING, Catalog # 70001B-07T.

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·November 29, 2023

    MAGNETOM Verio Dot Upgrade. Model Number: 10684334.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F

    FDA Recall
    Open, Classified ·Product code LRO·March 16, 2026

    BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060

    FDA Enforcement
    Class II ·Ongoing·BD SWITZERLAND SARL·June 18, 2025