BEUDAMED
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    The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Advansys DLP systems. Should the Drilling Guides need to be replaced, they can be replenished by the customer placing an order. The replacement is shipped to the customer in sealed plastic bags. Uni-CP" Compression Plate The Uni-CP" Compression Plate is indicated for fixation of bone fractures or for bone reconstruction: - Arthrodesis in foot and ankle surgery - Fracture management in the foot and ankle - Mono or bi-cortical osteotomies in the foot and ankle TIBIAXYS" Plates The Newdeal¿ TIBIAXYS" Plates are indicated For fixation of bone fractures or for bone reconstruction. Examples include Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal¿ TIBIAXYS" Plates must be fixed with the Newdeal Surfix¿ 3.5mm diameter fixation screws and lock-screws. ADVANSYS¿ Mid-Foot Plating System: Dorsal Lisfranc Plate (DLP) and Medical Lisfranc Plate (MLP) The Dorsal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints The Medial Lisfranc Plates are intended for bone fixation such as: arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus: - Lisfranc arthrodesis - Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint

    FDA Enforcement
    Class II ·Terminated·Integra Life Sci.·September 26, 2012

    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code NFJ·April 4, 2016

    Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·April 5, 2017

    First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet 3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 Deluxe Cabinet 3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLBCSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R 200 Person Deluxe Cabinet - Refill R508016 Eye Wash 4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet 316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36MDelmarva Power/ACEw/Logo R508016 Eye Wash4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC4 200 Person Deluxe Cabinet 4 Shelf R508016 Eye Wash4 oz. 32-000452-0000 K206140 CLX 100 Person Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV7SHStandard Cabinet Swing Out Door2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash

    FDA Recall
    Terminated ·Certified Safety Mfg Inc·Product code LRR·March 20, 2018

    Merge Eye Station and Merge Eye Care PACS.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code NFJ·April 4, 2016

    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code NFJ·March 28, 2016

    regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit

    FDA Recall
    Terminated ·ROi CPS LLC·Product code OJK·October 20, 2022

    Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·January 11, 2017

    First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet ¿3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3 ¿Deluxe Cabinet ¿3 Shelf R508016 Eye Wash - 4 oz. 32-000452-0000 K606999 ZLB¿CSX CPR Kit 37 R508016 Eye Wash " 4 oz. 32-000452-0000 KR206152 FAC " 4R ¿200 Person Deluxe Cabinet - Refill R508016 Eye Wash ¿4 oz. 32-000452-0000 K608054 Cement Burn Cabinet R511018 Eye Wash " 16 oz. 32-000454 0000- H5 K610045 FAC.3 " Deluxe Cabinet .w/BBP .NO MEDS .3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K606289 Eye Wash Cabinet ¿316 R511018 Eye Wash - 16oz 32-000454-0000-HS K608061 36M¿Delmarva Power/ACE¿w/Logo R508016 Eye Wash¿4 oz. 32-000452-0000 K611017 16PW " Hospeco " w/logo R508016 Eye Wash " 4 oz. 32-000452-0000 K206152 FAC¿4 ¿200 Person Deluxe Cabinet ¿4 Shelf R508016 Eye Wash¿4 oz. 32-000452-0000 K206140 CLX ¿100 Person ¿Deluxe Cabinet " 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 KR206210 FAC " 3R " Deluxe Cabinet ¿Refill R508016 Eye Wash " 4 oz 32-000452-0000 K209061 TRMK ¿Trauma Kit with Orange Co-Polymer Case R511018 Eye Wash -16 oz. 32-000454-0000-HS K206130 LXXV¿7SH¿Standard Cabinet Swing Out Door¿2 Shelf R508016 Eye Wash " 4 oz 32-000452-0000 Product Usage: various first aid/emergency kits containing eyewash

    FDA Enforcement
    Class II ·Terminated·Certified Safety Mfg Inc·April 18, 2018

    Merge Eye Station and Merge Eye Care PACS.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·April 26, 2017

    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 1, 2017

    Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. Model Number: I0016C, I0018C, I0020C, I0022C, I0024C. Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a resorbable shell that aids in implant insertion and provides a means of securing muscles to the implant. The Coated Bio-Eye Orbital Implant is indicated in orbital implantation following enucleation, or as a secondary orbital implant following extrusion, migration or rotation of primary orbital implants. It is indicated in any situation where materials such as silicone, acrylic, polyethylene or glass orbital implants would be used.

    FDA Recall
    Terminated ·Integrated Orbital Implants Inc·Product code hpz·May 20, 2011

    Eye Tray, part number PSS1834 Eye Tray, part number PSS1834(A

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    ¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 30, 2022

    EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OXQ·March 9, 2017

    POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.

    FDA Recall
    Terminated ·Centurion Medical Products Corporation·Product code OXQ·March 9, 2017

    Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection

    FDA Recall
    Terminated ·Covidien LLC·Product code HMP·March 3, 2017

    Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection

    FDA Recall
    Terminated ·Covidien LLC·Product code HMP·March 3, 2017

    Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use in the operating room, and for application to the eye following injury and or surgery in order to reduce the likelihood of introduction of infection

    FDA Recall
    Terminated ·Covidien LLC·Product code HMP·March 3, 2017

    DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye

    FDA Recall
    Terminated ·DeRoyal Industries Inc·Product code HOZ·August 12, 2013