BEUDAMED
    45 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Status: Terminated × Clear all

    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 11, 2019

    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical instrument Item Number: 475665

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 11, 2019

    Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 26, 2014

    Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 26, 2014

    Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 26, 2014

    C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx only ¿5.0GH 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch.

    FDA Enforcement
    Class II ·Terminated·Camlog Usa·September 25, 2013

    Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-ceramic (no metal) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks.

    FDA Enforcement
    Class II ·Terminated·Talladium Inc·September 16, 2020

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent AG·May 13, 2020

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent AG·May 13, 2020

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent AG·May 13, 2020

    Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.

    FDA Enforcement
    Class II ·Terminated·Medtronic Xomed, Inc.·October 2, 2013

    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195

    FDA Enforcement
    Class II ·Terminated·Ivoclar Vivadent AG·May 13, 2020

    Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·March 20, 2013

    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·May 27, 2015

    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·May 27, 2015

    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.

    FDA Enforcement
    Class II ·Terminated·ITC-Nexus Dx·November 13, 2013

    Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·October 19, 2016

    Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites.

    FDA Enforcement
    Class II ·Terminated·CompView Medical, LLC·January 20, 2016

    Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France The Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·April 17, 2013

    Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for Straumann milling centers 1334x. Lava Ultimate CAD/CAM Restorative for TS150, Compatible with TS150 (IOS Technologies), Glidewell Laboratories, 2614x. Lava Ultimate Restorative with Blue Mandrel, Pedestal Mandrel, compatible with Carestream CS 3000, Roland DWX-50, Roland DWX-4, 1314x, 2012x, 2110x. Lava Ultimate Restorative for Planmill, Compatible with Planmill mills, same mandrel format as E4D, 4212x, 4214x, 4312x, 4414x, 5072x, 5074x. Lava Ultimate Restorative for Ceramill, Compatible with Ceramill mills manufactured by Amann Girrbach, 4514x, 4714x, 5044x. Frame/Blank Version Used by Dental Laboratories: Lava Ultimate Implant Crown Restorative, Compatible with Lava Milling Equipment (Lava blocks bonded into frames. These are also known as blanks.), 69140-69149, 69150-69159, 69160-69163.

    FDA Enforcement
    Class II ·Terminated·3M Company - Health Care Business·July 15, 2015