BEUDAMED
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    PERFORMER HT/ HANG&GO HT BASIC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HANG&GO HT BASIC

    FDA Adverse Event
    Malfunction ·RAND S.R.L.·Product code LGZ·May 15, 2017

    ACE

    FDA UDI
    ACE SURGICAL SUPPLY CO., INC.·00614950010844·ELEVATOR PERIOSTEAL FREER DELICATE 7-1/2" 19CM

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707008880·CALIBRA 1ST MOLAR BANDS n.UR 26

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810057372209·Finger Trap Extra Small

    NA

    FDA UDI
    STRYKER CORPORATION·04546540992574·6.1mm x 3.8mm Side Cutting Drum

    SEASPINE SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RAVEN BACTERIAL SPORE STRIPS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFUSE BONE GRAFT 12 MG

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

    CORAIL2 NON COL HO SIZE 13

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·January 12, 2015

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 25, 2014

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·June 8, 2011

    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

    smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    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 Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code DTL·March 1, 2022

    Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 30, 2025