BEUDAMED
    32 results · 32ms · 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 ×

    E-Z PEN, REUSEABLE HANDSWITCHING PENCIL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481114748·LOCATOR F-Tx Abutment for Regular Platform (RP)...

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110566·LOCATOR R-Tx Abutment for Regular Platform (RP)...

    Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989025774·NITI CR TRU-ARCH 16 DIA UPR MED-BP/100

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065630·INTRAORAL ELASTICS 2,5 oz 1/8" brown

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481128738·LOCATOR R-Tx Abutment, Regular Platform (RP) Tr...

    P102, S102, 1', DP, CURBELL,NURSE CALL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828189910·P102, S102, 1', DP, CURBELL,NURSE CALL

    P102, S102, 1 FT, DP, CURBELL

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828139304·P102, S102, 1 FT, DP, CURBELL

    P102, S102, 1', DP, CURBELL,BED EXIT

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828189903·P102, S102, 1', DP, CURBELL,BED EXIT

    SONIC MODEL SO-300

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 10, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 30, 2014

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 23, 2020

    Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A, K09-YS029A, K09-YS040F, K12-YP002A, K12-YP030A, K12-YP060A, K12-YP061A, K12-YP063C, K12-YP072, K12-YS018A, K12-YS019A, K12-YS026A, K05-01140D, K05-01706C***, K05-02595, MAP112, K05-00564L, K12-YP002A,

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·April 20, 2022

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·September 2, 2024

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·July 17, 2025

    ENDURANT II STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·June 12, 2025

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·April 30, 2025