BEUDAMED
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    MED-RX PATIENT DELIVERY SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Apex

    FDA UDI
    ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529584931·Apex Tibial Nail Ø 12 x 375mm

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481476729·

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017619·Hook Punch Cut angular 3.5mm 45 degree right

    DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604

    FDA 510(k)
    FDA Class 2 ·Immunology

    THE NURTURE III BREAST PUMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    UNKNOWN DEPUY SROM HIP LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 20, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 10, 2011

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

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

    OPTILENE 8/0 (0,4) 60CM 2XDR8FB CV RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·June 30, 2023

    OPTILENE 8/0 (0,4) 60CM 2XDR8FB CV RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·June 30, 2023

    OPTILENE 8/0 (0,4) 60CM 2XDR8FB CV RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·June 30, 2023

    OPTILENE 8/0 (0,4) 60CM 2XDR8FB CV RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·June 30, 2023

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150/F, MAP152/B, MAP152/F, K12-01551, K12-YP064A, K12-YP114, K12-YP115, K12-YS047A, IN8152, K12-01551

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

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pressure Monitoring Kit), REF: K12-03846 K12-04185A K12-03447 K12M-02489 K12-10056 K12-02489A K12-02097B K12-12335 K12-12192P K12-12079P K12-04262BP K12-11132B K12-12382 K12-09098C K12-02112 K12-02111 K12-05576G K12-05805A K12T-10313C K12-11821P K12-01348D K12-11821 K12-11426 K12-06318 K12-12053 K12-03438 K12-07208A K12-12147 K12-09009 K12-10375 K12-08716 K12-11669AP K12-00657A K12-11131AP K12-10914 K12-07299P K12-05494 K12-00443A K12-08303 K12-06509A K12-10962 K12-11133 K12-06509B To support various vascular or cardiac diagnostic and interventional procedures.

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·June 11, 2024

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015