BEUDAMED
    31 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.

    FDA Enforcement
    Class II ·Terminated·Abeon Medical Corporation·January 27, 2016

    ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.

    FDA Enforcement
    Class II ·Terminated·Ethicon Endo-Surgery Inc·May 27, 2015

    Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    GENICON EZEE Retrieval, sterile, Rx only.

    FDA Enforcement
    Class II ·Terminated·Genicon, Inc.·March 28, 2018

    PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses.

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb Inc Irb·November 30, 2016

    Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.

    FDA Enforcement
    Class II ·Terminated·LeMaitre Vascular, Inc.·April 10, 2013

    Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical Center Santa Rosa

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.

    FDA Enforcement
    Class II ·Terminated·Konica Minolta Healthcare, Americas, Inc.·December 26, 2018

    Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.

    FDA Enforcement
    Class II ·Terminated·Ormco/Sybronendo·September 28, 2016

    Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·April 5, 2017

    CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.

    FDA Enforcement
    Class II ·Terminated·Biocare Medical, LLC·May 6, 2015