BEUDAMED
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    PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

    FDA Enforcement
    Class II ·Terminated·Gyrus Acmi, Incorporated·November 28, 2012

    GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.

    FDA Enforcement
    Class II ·Terminated·Gyrus Acmi, Incorporated·June 12, 2013

    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC

    FDA Enforcement
    Class II ·Terminated·Gyrus ACMI, Inc.·April 24, 2019

    Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS

    FDA Enforcement
    Class II ·Terminated·Gyrus ACMI, Inc.·April 24, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS

    FDA Enforcement
    Class II ·Terminated·Gyrus ACMI, Inc.·April 24, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS

    FDA Enforcement
    Class II ·Terminated·Gyrus ACMI, Inc.·April 24, 2019

    Olympus Diego Elite Console MDCONS 100

    FDA Enforcement
    Class II ·Terminated·Gyrus ACMI, Inc.·April 24, 2019

    Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA

    FDA Enforcement
    Class II ·Terminated·Gyrus ACMI, Inc.·April 24, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS

    FDA Enforcement
    Class II ·Terminated·Gyrus ACMI, Inc.·April 24, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC

    FDA Enforcement
    Class II ·Terminated·Gyrus ACMI, Inc.·April 24, 2019

    Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS

    FDA Enforcement
    Class II ·Terminated·Gyrus ACMI, Inc.·April 24, 2019

    Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC

    FDA Enforcement
    Class II ·Terminated·Gyrus ACMI, Inc.·April 24, 2019

    AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.

    FDA Enforcement
    Class II ·Terminated·Amd-Ritmed, Inc.·July 27, 2016

    AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150

    FDA Enforcement
    Class II ·Terminated·Amd-Ritmed, Inc.·December 14, 2016

    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040

    FDA Enforcement
    Class II ·Terminated·AMD Medicom Inc.·November 27, 2019

    MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042

    FDA Enforcement
    Class II ·Terminated·AMD Medicom Inc.·November 27, 2019

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 11.0 and 11.5 Product Usage: AMO TECNIS CL monofocal foldable IOLs with OptiEdge design are ultraviolet-absorbing posterior chamber intraocular lenses which compensate for corneal spherical aberrations. TECNIS CL Silicone Intraocular Lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.

    FDA Enforcement
    Class II ·Terminated·AMO Puerto Rico Manufacturing, Inc.·August 27, 2014

    TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016

    SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Enforcement
    Class II ·Terminated·Abbott Medical Optics Inc. (AMO)·September 28, 2016