BEUDAMED
    13 results · 47ms · Sources: EU EUDAMED, US FDA

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    Transport Endoscopic Access Device

    FDA UDI
    Usgi Medical, Inc.·00860009064751·Transport Endoscopic Access Device

    g-Lix Tissue Grabber

    FDA UDI
    Usgi Medical, Inc.·00860009064744·g-Lix Tissue Grabber

    g-Prox EZ Endoscopic Grasper

    FDA UDI
    Usgi Medical, Inc.·00860009064737·g-Prox EZ Endoscopic Grasper 33

    g-Cath Suture Anchor Delivery Catheter

    FDA UDI
    Usgi Medical, Inc.·00860009064713·g-Cath Suture Anchor Delivery Catheter

    g-Prox EZ Endoscopic Grasper

    FDA UDI
    Usgi Medical, Inc.·00860009064720·g-Prox EZ Endoscopic Grasper 16

    Transport Endoscopic Access Device

    FDA UDI
    Usgi Medical, Inc.·00860009064706·Transport Endoscopic Access Device

    Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·November 20, 2013

    Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·November 20, 2013

    Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·November 20, 2013

    Kimberly-Clark/Ballard TRACH CARE Wet Pack * Y Adapter * Closed Suction System for Neonates * Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) * Single Use * Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA

    FDA Recall
    Terminated ·Kimberly-Clark Corporation·Product code BSY·November 30, 2005

    Kimberly-Clark/Ballard TRACH CARE* - 72 Closed Suction products for Adults, Rx Only * Sterile * Diameter 14 Fr (4.6 mm), 54 cm (21.3 in) * Single Use * Made in Mexico, Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA.

    FDA Recall
    Terminated ·Kimberly-Clark Corporation·Product code BSY·November 30, 2005

    Kimberly-Clark/Ballard TRACH CARE* - 72 Wet Pak* for Adults * Closed Suction System with Saline Vials * Diameter 14 Fr (4.6 mm), Length 30.5 cm (12 in) * Rx Only * Single Use * Manufactured by Ballard Medical Products, Draper, Utah 84020 USA, Distributed in the US by Kimberly-Clark Global Sales, Inc., Roswell, GA 30076 USA.

    FDA Recall
    Terminated ·Kimberly-Clark Corporation·Product code BSY·November 30, 2005

    CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. by: Carestream Health, Inc., 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc·May 11, 2016