BEUDAMED
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    CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699557·GENUMEDI PSS BLUE SIZE III

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481133718·LOCATOR R-Tx Abutment, Keystone Conical, 3mm Cuff

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·10884450259297·

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017367·Hook Punch with Scoop 2.7mm 15 degree up

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017374·Hook Punch with Scoop 3.5mm 15 degree up

    ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XR PRIMER 2

    FDA 510(k)
    FDA Class 2 ·Dental

    STRATUS CS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015

    PENUMBRA SMART COIL

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code HCG·December 11, 2015

    STRATUS CS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013

    MICRUS ENDOVASCULAR CORPORATION

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR CORPORATION·Product code HCG·August 14, 2008

    3.00MM TI CERVICAL SPINE SCREW

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWP·June 2, 2011

    V.A.C. FREEDOM THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021

    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

    Diagnost 94

    FDA Recall
    Terminated ·Philips Medical Systems·Product code IZZ·February 20, 2002

    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