BEUDAMED
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    ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LOM·August 19, 2010

    McKesson Cardiology Hemo

    FDA Recall
    Terminated ·Change Healthcare Israel Ltd. 26, Ha-Rokmim Holon Israel·Product code DQK·March 25, 2019

    Horizon Cardiology Hemo

    FDA Recall
    Terminated ·Change Healthcare Israel Ltd. 26, Ha-Rokmim Holon Israel·Product code DQK·March 25, 2019

    The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalogue Number: LUK-17-150-4 The LumbarCool Pain Management System, a cooled radiofrequency pain management system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for use to create RF lesions in nervous tissue.

    FDA Recall
    Terminated ·Baylis Medical Corp·Product code GXI·May 12, 2010

    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food particles from between the teeth and below the gum line. The power handle can also function as a rechargeable battery powered mechanical toothbrush.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code JET·July 2, 2018

    Water Pik Sinusense battery operated device including a blue semi-transparent water reservoir, a white hand held button initiated injector device, and a soft seal nozzle affixed to the white injector. The product is sold individually in white, blue red and orange cartons with a photo of the device as well as a stream of water flowing through it. The contents of the container include the device as well as a package insert with utilization instructions. Product Usage: Sinus washing device to keep sinus passages clear of congestion.

    FDA Recall
    Terminated ·Water Pik, Inc.·Product code KMA·April 3, 2012

    Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding Protein (H-FABP) concentration in serum, citrate-plasma, EDTA-plasma, and heparin-plasma.

    FDA Recall
    Terminated ·BioCheck Inc·Product code NUK·July 15, 2010

    X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.

    FDA Recall
    Terminated ·XTANT Medical·Product code PEK·December 29, 2021

    BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code PQK·April 12, 2019

    HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

    FDA Recall
    Terminated ·Biomet UK Ltd. Waterton Industrial Estate Bridgend United Kingdom·Product code JDO·August 9, 2018

    HipLOC Hip Fracture Fixation System- Hiploc System 130 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

    FDA Recall
    Terminated ·Biomet UK Ltd. Waterton Industrial Estate Bridgend United Kingdom·Product code JDO·August 9, 2018

    HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

    FDA Recall
    Terminated ·Biomet UK Ltd. Waterton Industrial Estate Bridgend United Kingdom·Product code JDO·August 9, 2018

    HipLOC Hip Fracture Fixation System-Hiploc System 140 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures

    FDA Recall
    Terminated ·Biomet UK Ltd. Waterton Industrial Estate Bridgend United Kingdom·Product code JDO·August 9, 2018