16 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
FDA Enforcement
Class II
·Terminated·Aesculap Implant Systems LLC·November 2, 2016
Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
FDA Enforcement
Class II
·Terminated·Covidien LLC·September 9, 2015
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
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
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo" Connector, REF/Catalog Number 2602M Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).
FDA Enforcement
Class II
·Terminated·ConMed Corporation·April 4, 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 Enforcement
Class II
·Terminated·Biomet UK Ltd.·October 3, 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 Enforcement
Class II
·Terminated·Biomet UK Ltd.·October 3, 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 Enforcement
Class II
·Terminated·Biomet UK Ltd.·October 3, 2018
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 Enforcement
Class II
·Terminated·Biomet UK Ltd.·October 3, 2018
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