BEUDAMED
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    OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.

    FDA Enforcement
    Class II ·Terminated·Novapproach Spine LLC·November 23, 2022

    Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.

    FDA Enforcement
    Class II ·Terminated·Heraeus Kulzer, LLC.·May 28, 2014

    Microtainer Safety flow Lancets; Yellow Sterile Use once and discard; 2.2mm Blade Length; 1.0mm blade width; Becton Dickinson Vacutainer System; Becton Dickinson and Company; Franklin Lakes, NJ 07417

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code F·September 26, 2007

    Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMK·September 26, 2007

    Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade Length; 1.0 mm Blade Width; Becton Dickinson Vacutainer Systems Becton dickinson and COmpany; Franklin Lakes, NJ 07417

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code F·September 26, 2007

    Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.

    FDA Enforcement
    Class II ·Terminated·Zimmer Gmbh·May 6, 2015

    Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

    FDA Enforcement
    Class II ·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·May 18, 2022

    Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses are cleared for use in the US only: Gastrointestinal and Affiliated Organ Surgery including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy Urological surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy General Surgery including removal of benign or malignant tumors or other unwanted soft tissue in open or minimally invasive general surgical procedures Laparoscopic Surgery including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·March 7, 2018

    Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·April 24, 2013

    Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

    FDA Enforcement
    Class II ·Terminated·Edwards Lifesciences, LLC·April 24, 2013

    EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

    EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

    EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 7, 2018

    Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·November 18, 2015

    Medtronic Physio-Control LIFEPAK CR Plus Defibrillator/Monitor. Automated external defibrillator deployed primarily in public access defibrillator environments where the expected use for any one device is once every 20 months. For use on persons requiring defibrillation therapy.

    FDA Recall
    Terminated ·Physio Control, Inc.·Product code MKJ·July 31, 2009

    Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20126

    FDA Enforcement
    Class II ·Terminated·Geistlich Pharma North America, Inc.·December 2, 2020

    Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115

    FDA Enforcement
    Class II ·Terminated·Geistlich Pharma North America, Inc.·December 2, 2020

    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·July 27, 2016

    LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·September 21, 2016

    CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.

    FDA Enforcement
    Class II ·Terminated·AGFA Corp.·March 27, 2013