BEUDAMED
    31 results · 13ms · Sources: EU EUDAMED, US FDA

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    BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.

    FDA Enforcement
    Class II ·Terminated·Kerr Corporation·November 28, 2012

    St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353

    FDA Enforcement
    Class II ·Terminated·St Jude Medical·November 12, 2014

    Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 18, 2015

    Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·April 20, 2016

    NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701

    FDA Enforcement
    Class II ·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·August 24, 2022

    NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697

    FDA Enforcement
    Class II ·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·August 24, 2022

    Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224

    FDA Enforcement
    Class II ·Terminated·Medical Action Industries, Inc. 306·June 30, 2021

    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·February 17, 2021

    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·February 17, 2021

    Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media. It includes functions for image manipulation, basic measurements and 3D visualization (reconstructions and volume rendering). Features for navigation planning include multi-modality image fusion as well as object and trajectory creation. It is not intended for primary image diagnosis or the review of mammographic images.

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·November 11, 2015

    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·June 14, 2017

    Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 33cm Length, Product number P0019 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries

    FDA Enforcement
    Class II ·Terminated·Progressive Medical Inc·May 29, 2013

    Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly

    FDA Enforcement
    Class II ·Terminated·Acutus Medical Inc·April 29, 2020

    - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm. REF AR-4068-25TL Lot 122518 and Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight Curve Right, w/Nitinol Wire Loop, (Lt. Green) 1.8mm. REF AR-4068-25TR Lot 122518 and Lot 123190. - Arthrex SutureLasso SD, 90 Degrees (Black) 1.8mm. REF AR-4068-90 Lot 122504. - Arthrex SutureLasso, 45 Degree, Perforating Needle Cannula, w/Suture Loop, (Lt. Grey). REF AR-4065S Lot 122590. -SutureLasso, w/Wire Loop, 90 Degree, (Blue) REF AR-4065-90W Lot 123263. Manual surgical instrument for general use

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White) 5.0mm x 36cm Ref. ACE36E Lot 122295, 122308, 122762 Unclassified

    FDA Enforcement
    Class II ·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013

    STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,

    FDA Enforcement
    Class II ·Ongoing·Stradis Medical, LLC dba Stradis Healthcare·December 21, 2022

    RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular device that is inserted through the urethera and is used to pass fluids to or from urinary tracts.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·June 18, 2014

    Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·January 2, 2013

    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·February 17, 2021

    Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·February 17, 2021