BEUDAMED
    21 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 ×

    CONCENTRIC BALLOON GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517574145·CoRoent Ant TLIF Ti, 11x12x40mm 4°

    2540 BALLOON VALVE

    FDA UDI
    HANS RUDOLPH, INC.·00874750008728·2540B 4WAYINFLBAL TSHP 1.125OD

    TLIF/PLIF Disc Prep

    FDA UDI
    Life Spine, Inc.·00190837086800·

    K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)

    FDA 510(k)
    FDA Class 2 ·Dental

    BRAUN

    FDA Adverse Event
    Injury ·B.BRAUN MEDICAL INC.·Product code KPE·September 29, 2008

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 14, 2013

    ENDOPATH STEALTH CIR STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code KOG·June 3, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025

    Disposable Water Trap with ''T'' for Ventilator Circuits; product reorder 6090; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

    FDA Recall
    Terminated ·Medex Inc·Product code BYH·July 12, 2004

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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