BEUDAMED
    26 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·August 12, 2015

    30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·August 12, 2015

    A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·February 21, 2018

    Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Synvasive Technology Inc·April 24, 2013

    Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·December 27, 2017

    Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·December 27, 2017

    Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·December 27, 2017

    Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·August 10, 2016

    Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 16, 2016

    A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·February 21, 2018

    Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·August 10, 2016

    Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·August 10, 2016

    Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·August 10, 2016

    Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·August 10, 2016

    Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·August 10, 2016

    Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·August 10, 2016

    Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·June 12, 2013

    Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·June 12, 2013

    The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·June 12, 2013

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014