BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ClearPoint System

    FDA 510(k)
    FDA Class 2 ·Neurology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011279·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 5

    Innomed, Inc.

    FDA UDI
    INNOMED, INC.·00840277101082·Cheng .250 Diameter Dilator Shaft

    OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HTO PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BELLATEK® ABUTMENT TSV 3.5MM

    FDA Adverse Event
    Malfunction ·ZIMVIE US CORP LLC·Product code NHA·March 3, 2026

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376668062·12mm CORE, NANOTEC KBN 14 x 25 mm 5°

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376667638·12mm CORE, NANOTEC BAN 14 x 25 mm 5°

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·April 16, 2014

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code NHA·February 5, 2021

    ABUTMENT, PATIENT SPECIFIC, TITANIUM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·June 26, 2017

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    BELLATEK ABUTMENT TSV 4.5MM

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·October 30, 2020

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·October 6, 2014

    LEGACY WELD REPLACEMENT, GRAY

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 3, 2013

    DYNASTY(R) A-CLASS(R) POLY LINER

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·June 28, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

    Baxter Minivolume Extension Set, 72'', product code 2C5687; An Rx sterile, nonpyrogenic fluid pathway, 72'', 1.6 mL Vol., with a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·August 3, 2005