BEUDAMED
    21 results · 29ms · Sources: EU EUDAMED, US FDA

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    Sysmex XW-100 Automated Hematology Analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56

    FDA Enforcement
    Class II ·Ongoing·LeMaitre Vascular, Inc.·May 21, 2025

    Pruitt Occlusion Catheter

    FDA UDI
    Lemaitre Vascular, Inc.·00840663101597·Pruitt Occlusion Catheter, 4F, eIFU

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551039457·COMPASS SPLIT CANNULA BUSHING

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319707111·Aufricht Glabela Rasp 8-1/4" (20.6cm), curved b...

    Pruitt Occlusion Catheter

    FDA UDI
    Lemaitre Vascular, Inc.·00840663101566·Pruitt Occlusion Catheter, 4F

    Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56

    FDA Recall
    Open, Classified ·LeMaitre Vascular, Inc.·Product code DYG·April 11, 2025

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450394717·

    Graseby

    FDA UDI
    ICU MEDICAL, INC.·00610586100478·

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·October 8, 2020

    KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR

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

    CLEANER ROTATIONAL THROMBECTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    AUTOPULSE® LI-ION BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code DRM·October 29, 2014

    PACKAGED VALVE PROGRAMMABLE UN

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·August 9, 2011

    VITALITY

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    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

    Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C820 (Reorder No. 21-0346-25) Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 Injection site.

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code FPA·December 3, 2004

    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

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014