39 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·July 20, 2016
Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·July 20, 2016
Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·January 15, 2020
Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HWE·May 31, 2016
Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
FDA Recall
Terminated
·Synthes (USA) Products LLC·Product code HWE·May 31, 2016
Aortic Valve & Conduit
FDA Recall
Terminated
·CryoLife, Inc.·Product code MIE·April 17, 2007
CryoValve, Pulmonary Valve & Conduit
FDA Recall
Terminated
·CryoLife, Inc.·Product code MIE·April 17, 2007
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
FDA Recall
Terminated
·Abbott Spine·Product code NKB·July 18, 2007
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
FDA Recall
Terminated
·Abbott Spine·Product code NKB·July 18, 2007
Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·April 18, 2007
Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code JOH·September 18, 2007
Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034
FDA Recall
Terminated
·Aesculap Inc·Product code HCI·November 1, 2007
Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT430T, Casper Applier F/Std Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034
FDA Recall
Terminated
·Aesculap Inc·Product code HCI·November 1, 2007
Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare". Snare Catheter
FDA Recall
Terminated
·Product code DXE·May 18, 2007
Anspach Single Use, Sterile Bone Cutting Burrs
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBB·May 18, 2007
GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular)
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·March 26, 2007
GE Healthcare Innova 4100/4100 IQ. Digital Fluoroscopic Imaging System (Vascular Angiography System)
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·March 26, 2007
GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System (Cardiovascular Imaging System)
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code MQB·March 26, 2007
Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator.
FDA Recall
Terminated
·Varian Medical Systems Inc·Product code IYE·April 18, 2007
LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.
FDA Recall
Terminated
·Lifescan Inc·Product code NBW·December 18, 2007