BEUDAMED
    76 results · 7ms · Sources: EU EUDAMED, US FDA

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

    Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.

    FDA Enforcement
    Class II ·Terminated·Zimmer Manufacturing B.V.·March 23, 2016

    CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.

    FDA Enforcement
    Class II ·Terminated·Linvatec Corp. dba ConMed Linvatec·August 15, 2012

    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·August 21, 2013

    ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.

    FDA Enforcement
    Class II ·Terminated·Coltene Whaledent Inc·November 14, 2018

    Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.

    FDA Enforcement
    Class II ·Terminated·Sorin Group USA, Inc.·September 14, 2016

    Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.

    FDA Enforcement
    Class II ·Terminated·Anjon Holdings·August 19, 2020

    Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.

    FDA Enforcement
    Class II ·Terminated·Medtest Holdings, Inc.·June 7, 2017

    Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.

    FDA Enforcement
    Class II ·Terminated·Medtest Holdings, Inc.·July 6, 2016

    Cervical Extension Machine for Physical Therapy

    FDA Enforcement
    Class II ·Terminated·MedX Holdings, Inc.·January 14, 2015

    Lumbar Extension Machine for Physical Therapy

    FDA Enforcement
    Class II ·Terminated·MedX Holdings, Inc.·January 14, 2015

    Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.

    FDA Enforcement
    Class II ·Terminated·Medtest Holdings, Inc.·June 21, 2017

    Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91

    FDA Enforcement
    Class II ·Terminated·SunMed Holdings, LLC·October 5, 2022

    VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.

    FDA Enforcement
    Class II ·Terminated·Spine Smith Holdings, LLC·September 25, 2013

    OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

    FDA Enforcement
    Class II ·Terminated·Matrix Surgical Holdings, LLC·March 8, 2017

    OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

    FDA Enforcement
    Class II ·Terminated·Matrix Surgical Holdings, LLC·May 8, 2019

    OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

    FDA Enforcement
    Class II ·Terminated·Matrix Surgical Holdings, LLC·May 8, 2019

    Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·February 12, 2014

    Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·February 20, 2013

    Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·November 20, 2013

    Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K

    FDA Enforcement
    Class II ·Terminated·Fresenius Medical Care Holdings, Inc.·May 21, 2014