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Data / Medical devices / United States / Medtronic Distribution Center

Medtronic Distribution Center: FDA-registered device maker in Memphis, TN, United States, 164 510(k) clearances and 33 PMA approvals

Medtronic Distribution Center is registered with the FDA (registration 3009380063) in Memphis, TN, United States. It lists 110 device types. The FDA files 164 510(k) clearances and 33 PMA approvals under its listings, the newest dated July 14, 2026. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number
3009380063
Address
5300 Airways Blvd, Memphis, TN, United States, 38116
Owner or operator
Medtronic, Inc. (2112641)
Roles
Manufacturer, Repackager or relabeler
First device listed
December 12, 1992
Registered through
2027
Brand names listed
, MOTORS, ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology, AURORA EV-ICD™ MRI SURESCAN™ SW041, AUTOSUTURE ENDOSCOPIC CLAMP, Abre™ Venous Self-expanding Stent System, AbsorbaTack, Absorbatack, Access Review Therapy Controller and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Repackager or relabeleraccessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassDTL2Repackager or relabeleraccessdata.fda.gov
Agent, Injectable, EmbolicMFE3Repackager or relabeleraccessdata.fda.gov
Anoscope And AccessoriesFER2Manufactureraccessdata.fda.gov
Anti Fog Solution And Accessories, EndoscopyOCT2Manufactureraccessdata.fda.gov
Aortic Valve, Prosthesis, Percutaneously DeliveredNPT3Repackager or relabeleraccessdata.fda.gov
Apparatus, AutotransfusionCAC2Manufactureraccessdata.fda.gov
Apparatus, Exhaust, SurgicalFYD2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal InterlaminalKWP2Repackager or relabeleraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Repackager or relabeleraccessdata.fda.gov
Applier, Surgical, ClipGDO1Manufactureraccessdata.fda.gov
AwlHWJ1Repackager or relabeleraccessdata.fda.gov
BenderHXW1Repackager or relabeleraccessdata.fda.gov
Bit, DrillHTW1Repackager or relabeleraccessdata.fda.gov
Bone Fixation Cerclage, SublaminarOWI2Repackager or relabeleraccessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDWF2Repackager or relabeleraccessdata.fda.gov
Catheter, Continuous FlushKRA2Repackager or relabeleraccessdata.fda.gov
Catheter, PercutaneousDQY2Repackager or relabeleraccessdata.fda.gov
Catheter, Percutaneous, NeurovasculatureQJP2Repackager or relabeleraccessdata.fda.gov
Catheter, Thrombus RetrieverNRY2Repackager or relabeleraccessdata.fda.gov
Clip, ImplantableFZP2Manufactureraccessdata.fda.gov
Coronary Drug-Eluting StentNIQ3Repackager or relabeleraccessdata.fda.gov
Cutter, SurgicalFZT1Repackager or relabeleraccessdata.fda.gov
Deep Brain Stimulation For The Treatment Of DystoniaSGS3Repackager or relabeleraccessdata.fda.gov
Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)OLMfRepackager or relabeleraccessdata.fda.gov
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK3Repackager or relabeleraccessdata.fda.gov
Detector And Alarm, ArrhythmiaDSI2Repackager or relabeleraccessdata.fda.gov
Device, Neurovascular EmbolizationHCG2Repackager or relabeleraccessdata.fda.gov
Device, Vascular, For Promoting EmbolizationKRD2Repackager or relabeleraccessdata.fda.gov
Dispenser, CementKIH1Repackager or relabeleraccessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE2Repackager or relabeleraccessdata.fda.gov
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX3Repackager or relabeleraccessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN3Repackager or relabeleraccessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty CatheterONU3Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Endoscopic Tissue Approximation DeviceOCW2Manufactureraccessdata.fda.gov
Endovascular Suturing SystemOTD2Repackager or relabeleraccessdata.fda.gov
ExtractorHWB1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, ObstetricalHDA2Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Repackager or relabeleraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)LWS3Repackager or relabeleraccessdata.fda.gov
Implantable Pacemaker Pulse-GeneratorDXY3Repackager or relabeleraccessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)LWP3Repackager or relabeleraccessdata.fda.gov
Implanted Electrical Device Intended For Treatment Of Fecal IncontinenceQON3Repackager or relabeleraccessdata.fda.gov
Implanted Subcortical Electrical Stimulator (Motor Disorders)MRUfRepackager or relabeleraccessdata.fda.gov
Instrument, CompressionHWN1Repackager or relabeleraccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Repackager or relabeleraccessdata.fda.gov
Instrument, Ultrasonic SurgicalLFLUManufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Repackager or relabeleraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Repackager or relabeleraccessdata.fda.gov
Intracranial Aneurysm Flow DiverterOUT3Repackager or relabeleraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Manufactureraccessdata.fda.gov
Laryngoscope, EndoscopeGCI2Manufactureraccessdata.fda.gov
Leadless PacemakerPNJ3Repackager or relabeleraccessdata.fda.gov
Light, Surgical, CarrierFSZ2Repackager or relabeleraccessdata.fda.gov
Mesh, Surgical, Absorbable, Staple Line ReinforcementOXC2Manufactureraccessdata.fda.gov
Mesh, Surgical, PolymericFTL2Manufactureraccessdata.fda.gov
Neurovascular Liquid Embolic AgentSGU3Repackager or relabeleraccessdata.fda.gov
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke TreatmentPOL2Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Repackager or relabeleraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Repackager or relabeleraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Repackager or relabeleraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Repackager or relabeleraccessdata.fda.gov
OsteotomeHWM1Repackager or relabeleraccessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted ComponentsOSR3Repackager or relabeleraccessdata.fda.gov
Pedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOSH2Repackager or relabeleraccessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible ElectroporationQZI3Repackager or relabeleraccessdata.fda.gov
Peripheral Mechanical Thrombectomy With AspirationQEW2Repackager or relabeleraccessdata.fda.gov
Permanent Defibrillator ElectrodesNVY3Repackager or relabeleraccessdata.fda.gov
Permanent Pacemaker ElectrodeDTB3Repackager or relabeleraccessdata.fda.gov
Pneumoperitoneum NeedleFHO2Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Repackager or relabeleraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Manufactureraccessdata.fda.gov
ProbeHXB1Repackager or relabeleraccessdata.fda.gov
Programmer, PacemakerKRG3Repackager or relabeleraccessdata.fda.gov
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE3Repackager or relabeleraccessdata.fda.gov
Pulse Generator, Permanent, ImplantableNVZ3Repackager or relabeleraccessdata.fda.gov
Pump, Blood, Cardiopulmonary Bypass, Non-Roller TypeKFM2Repackager or relabeleraccessdata.fda.gov
ReamerHTO1Repackager or relabeleraccessdata.fda.gov
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)MXD2Repackager or relabeleraccessdata.fda.gov
RetractorGAD1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Repackager or relabeleraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeleraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Repackager or relabeleraccessdata.fda.gov
Staple, ImplantableGDW2Manufactureraccessdata.fda.gov
Staple, Removable (Skin)GDT1Manufactureraccessdata.fda.gov
Stapler, SurgicalGAG2Manufactureraccessdata.fda.gov
Stent, Iliac VeinQAN3Repackager or relabeleraccessdata.fda.gov
Stimulator, Brain, Implanted, For Behavior ModificationMFRfRepackager or relabeleraccessdata.fda.gov
Stimulator, Electrical, Implantable, For IncontinenceEZW3Repackager or relabeleraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Essential TremorPJS3Repackager or relabeleraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian SymptomsNHL3Repackager or relabeleraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY3Repackager or relabeleraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW3Repackager or relabeleraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyQRB3Repackager or relabeleraccessdata.fda.gov
Stimulator, Thalamic, Epilepsy, ImplantedMBX3Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Manufactureraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Manufactureraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Manufactureraccessdata.fda.gov
System, Endovascular Graft, Aortic Aneurysm TreatmentMIH3Repackager or relabeleraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Repackager or relabeleraccessdata.fda.gov
Tissue Adhesive For The Topical Approximation Of SkinMPN2Manufactureraccessdata.fda.gov
Tubing, Pump, Cardiopulmonary BypassDWE2Repackager or relabeleraccessdata.fda.gov
Wire, Guide, CatheterDQX2Repackager or relabeleraccessdata.fda.gov
WrenchHXC1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 164.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 14, 2026K261020Symmetrix™ L Spinal SystemMAXSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
April 21, 2026K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemNKBSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
January 21, 2026K254165Infinity™ OCT SystemNKGSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
January 7, 2026K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)NKBSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
October 24, 2025K253129Infinity™ OCT SystemNKGSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
June 11, 2025K250787Liberant Thrombectomy SystemQEWSubstantially EquivalentMedtronic, Irelandaccessdata.fda.gov
October 28, 2024K241992Catalyft™ LS Expandable Interbody SystemOVDSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
October 23, 2024K243007CD Horizon™ Spinal SystemNKBSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
August 16, 2023K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)NKBSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
July 18, 2023K230716Robotic Graft Delivery InstrumentsOLOSubstantially EquivalentMedtronic Sofamor Danek, Inc.accessdata.fda.gov
May 26, 2023K231184CD Horizon™ Spinal SystemOLOSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
January 23, 2023K223494CD Horizon Spinal SystemNKBSubstantially EquivalentMedtronicaccessdata.fda.gov
May 25, 2022K221244CD Horizon™ Spinal SystemNKBSubstantially EquivalentMedtronicaccessdata.fda.gov
May 28, 2021K211304LINQ II Insertable Cardiac MonitorMXDSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
March 1, 2021K203358Solitaire X Revascularization DevicePOLSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
September 14, 2020K202318Marathon Flow Directed Micro CatheterKRASubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
July 3, 2020K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool KitMXDSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
December 6, 2019K192443Dextile Anatomical MeshFTLSubstantially EquivalentSofradim Productionaccessdata.fda.gov
August 6, 2019K191565Endoskeleton TCS Interbody Fusion DeviceOVESubstantially EquivalentTitan Spine, Inc.accessdata.fda.gov
April 4, 2019K183197PYRAMESH™ Implant SystemMQPSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
December 18, 2018K183185Riptide Aspiration System (Riptide Large Bore Aspiration System)NRYSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
November 21, 2018K182957Heli-FX EndoAnchor SystemOTDSubstantially EquivalentMedtronic Vascular, Inc.accessdata.fda.gov
October 25, 2018K181186Solitare Platinum Revascularization DevicePOLSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
June 21, 2018K181085LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coatedGEISubstantially EquivalentCovidienaccessdata.fda.gov
March 26, 2018K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion GuideLFLSubstantially EquivalentCovidien, LLCaccessdata.fda.gov
March 2, 2018K173281LigaSure Exact Dissector, Nano-coatedGEISubstantially EquivalentCovidienaccessdata.fda.gov
February 20, 2018K173270Tri-Staple 2.0 Reinforced ReloadGDWSubstantially EquivalentCovidienaccessdata.fda.gov
October 5, 2017K171689ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC TechnologyMAXSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
June 13, 2017K171427Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTDSubstantially EquivalentMedtronic Vascular, Inc.accessdata.fda.gov
April 21, 2017K170869LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedGEISubstantially EquivalentCovidienaccessdata.fda.gov
March 8, 2017K163654VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocarGCJSubstantially EquivalentCovidien, LLCaccessdata.fda.gov
March 8, 2017K160641Solitaire Platinum Revascularization Device, 6x40 mmNRYSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
February 23, 2017K162855Reveal LINQMXDSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
January 3, 2017K162704Axium Prime Detachable Coil SystemHCGSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
December 5, 2016K163098Tri-Staple 2.0 Intelligent CartridgeGDWSubstantially EquivalentCovidien, LLCaccessdata.fda.gov
November 30, 2016K163102ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmGCJSubstantially EquivalentCovidienaccessdata.fda.gov
November 14, 2016K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedGEISubstantially EquivalentCovidienaccessdata.fda.gov
November 10, 2016K162539Solitaire 2 Revascularization DevicePOLSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
September 21, 2016K161879Solitaire Platinum Revascularization DeviceNRYSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
September 16, 2016K161804LigaSure Retractable L-Hook Laparoscopic Sealer/DividerGEISubstantially EquivalentCovidienaccessdata.fda.gov
April 26, 2016K160176Signia StaplerGDWSubstantially EquivalentCovidienaccessdata.fda.gov
March 1, 2016K160230VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mmGCJSubstantially EquivalentCovidienaccessdata.fda.gov
January 5, 2016K153265New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coatedGEISubstantially EquivalentNew Deantronics Taiwan , Ltd.accessdata.fda.gov
December 23, 2015K153071Solitaire Platinum Revascularization DeviceNRYSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
October 26, 2015K151182LiquiBand ExceedMPNSubstantially EquivalentAdvanced Medical Solutions (Plymouth), Ltd.accessdata.fda.gov
September 14, 2015K143644Premium Surgiclip¿; Endo Clip¿; AcuClip¿FZPSubstantially EquivalentCovidienaccessdata.fda.gov
July 28, 2015K151447Axium Detachable Coil SystemHCGSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
July 2, 2015K151548VersaOne Bladed Trocar, VersaOne Bladeless TrocarGCJSubstantially EquivalentCovidienaccessdata.fda.gov
June 18, 2015K151356Spacemaker Pro Access and Dissector SystemGCJSubstantially EquivalentCovidien, LLCaccessdata.fda.gov
January 7, 2015K143107DLP Vein Graft CannulaDWFSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
December 9, 2014K142547Bluntport Blunt Trocar with Threaded Anchor 5mm-12mmGCJSubstantially EquivalentCovidienaccessdata.fda.gov
August 7, 2014K141371SONICISION CORDLESS ULTRASONIC DISSECTORLFLSubstantially EquivalentCovidien, Formerly Valleylab, A Division of Tyco Haccessdata.fda.gov
July 2, 2014K140055ENDOSKELETON(R) TL INTERBODY FUSION DEVICEMAXSubstantially EquivalentTitan Spine, LLCaccessdata.fda.gov
May 22, 2014K140454NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPSOLOSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
May 16, 2014K141041APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTEOTDSubstantially EquivalentAptus Endosystemsaccessdata.fda.gov
February 14, 2014K132649REVEAL LINQ INSERTABLE CARDIAC MONITORMXDSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
February 6, 2014K140036APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITHOTDSubstantially EquivalentAptus Endosystems, Inc.accessdata.fda.gov
January 10, 2014K133310AXIUM DETACHABLE COIL SYSTEMHCGSubstantially EquivalentMicro Therapeutics, Inc. d/b/a ev3 Neurovascularaccessdata.fda.gov
April 12, 2013K130677APTUS HELI-FX AORTIC SECUREMENT SYSTEMOTDSubstantially EquivalentAptus Endosystems, Inc.accessdata.fda.gov
March 14, 2013K130435VERSAPORT V2 BLADELESS OPTICAL TROCARGCJSubstantially EquivalentCovidien, Formerly US Surgical A Divison of Tyco Haccessdata.fda.gov
December 11, 2012K123479PROGRIP LAPAROSCOPIC SELF-FIXATING MESHFTLSubstantially EquivalentSofradim Productionaccessdata.fda.gov
August 29, 2012K121760CAPSTONE SPINAL SYSTEMMAXSubstantially EquivalentMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
August 21, 2012K121764CD HORIZON SPINAL SYSTEMNKBUnknownMedtronic Sofamor Danek, Inc.accessdata.fda.gov
August 8, 2012K121168APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTHOTDSubstantially EquivalentAptus Endosystems, Inc.accessdata.fda.gov
August 1, 2012K113289ORION MICRO CATHETERKRASubstantially EquivalentMicro Therapeutics, Inc.accessdata.fda.gov
July 26, 2012K121982SOVEREIGN SPINAL SYSTEMOVDSubstantially EquivalentMedtronic Sofamor Danekaccessdata.fda.gov
July 5, 2012K121680CD HORIZON SPINAL SYSTEMNKBUnknownMedtronic Sofamor Danek USA, Inc.accessdata.fda.gov
June 29, 2012K121330WAVE O CAGEMAXSubstantially EquivalentAdvanced Medical Technologies AGaccessdata.fda.gov
June 29, 2012K120897PROGRIP LAPARSCOPIC SELF-FIXATING MESHFTLSubstantially EquivalentSofradim Productionaccessdata.fda.gov
May 29, 2012K110472SI-FIX SACROILIAC JOINT FUSION SYSTEMOURSubstantially EquivalentMedtronic Sofamor Danekaccessdata.fda.gov
February 24, 2012K11345414 WIRE STANDARD, 14 WIRE LSDQXSubstantially EquivalentMicro Therapeutics, Inc.accessdata.fda.gov
November 21, 2011DEN100026APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTEOTDUnknownAptus Endosystems, Inc.accessdata.fda.gov
October 25, 2011K111825ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERSGDWSubstantially EquivalentCovidien, Formerly US Surgical A Divison of Tyco Haccessdata.fda.gov
September 1, 2011K112349VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCARGCJSubstantially EquivalentCovidien, Formerly US Surgical A Divison of Tyco Haccessdata.fda.gov
June 3, 2011K111442V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)...GAMSubstantially EquivalentCovidien, Formerly US Surgical A Divison of Tyco Haccessdata.fda.gov
May 4, 2011K103764REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528DSISubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
April 5, 2011K110055REVERSE MEDICAL REFLEX GUIDE CATHETERDQYSubstantially EquivalentReverse Medical Corporationaccessdata.fda.gov
March 16, 2011K103375PLUMEPEN INTEGRATED SMOKE EVACUATION PENCILGEISubstantially EquivalentMedtek Devices, Inc.accessdata.fda.gov
February 24, 2011K103253SILS PORTGCJSubstantially EquivalentCoviden (Formerly Registered AS US Surgical, A Divaccessdata.fda.gov
February 17, 2010K100242AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTERFZPSubstantially EquivalentSurgical Devices, A Division of Tyco Healthcareaccessdata.fda.gov
December 9, 2009K093750ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBAKRASubstantially EquivalentEv3, Inc.accessdata.fda.gov
November 12, 2009K093402AUTOSUTURE EEA ORVILGDWSubstantially EquivalentSurgical Devices, A Global Business Unit Tycoaccessdata.fda.gov
September 1, 2009K091869SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARSGCJSubstantially EquivalentCovidien Lp, Formerly Registered AS United Statesaccessdata.fda.gov
May 14, 2009K090470AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICESOCWSubstantially EquivalentCovidienaccessdata.fda.gov
April 22, 2009K091087MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICEGAMSubstantially EquivalentSurgical Devices, Tyco Healthcare Group LPaccessdata.fda.gov
April 15, 2009K083714ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)MAXSubstantially EquivalentTitan Spine, LLCaccessdata.fda.gov
February 27, 2009K090046CONCERTO DETACHABLE COIL SYSTEMKRDSubstantially EquivalentMicro Therapeutics, Inc.accessdata.fda.gov
August 19, 2008K081465AXIUM DETACHABLE COIL SYSTEMKRDSubstantially EquivalentMicro Therapeutics, Inc.accessdata.fda.gov
May 28, 2008K081050PARIETEX PROGRIP MESHFTLSubstantially EquivalentSofradim Productionaccessdata.fda.gov
May 23, 2008K081169AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCARGCJSubstantially EquivalentCovidien Lp, Formerly Registered AS United Statesaccessdata.fda.gov
September 28, 2007K071920AUTOSUTURE ABSORBABLE TACK AND APPLICATORGDWSubstantially EquivalentUnited States Surgical, A Division of Tyco Healthcaccessdata.fda.gov
October 23, 2006K062850AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERSGDWSubstantially EquivalentUnited States Surgical, A Division of Tyco Healthcaccessdata.fda.gov
October 5, 2006K062779DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)GCJSubstantially EquivalentNew Wave Surgical Corporationaccessdata.fda.gov
June 23, 2006K061254EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222DWFSubstantially EquivalentMedtronic Perfusion Systemsaccessdata.fda.gov
November 22, 2005K052524BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KITDWFSubstantially EquivalentMedtronic Perfusion Systemsaccessdata.fda.gov
September 22, 2005K052372MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437CDWFSubstantially EquivalentMedtronic Perfusion Systemsaccessdata.fda.gov
July 22, 2005K051627VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENTGEISubstantially EquivalentValleylabaccessdata.fda.gov
April 13, 2005K050038RELIANT STENT GRAFT BALLOON CATHETERDQYSubstantially EquivalentMedtronic Endovascular Innovationsaccessdata.fda.gov
February 23, 2005K043602QUADRANT RETRACTOR SYSTEMGADSubstantially EquivalentMedtronic Sofamor Danekaccessdata.fda.gov
February 8, 2005K043179SELECT 3D ARTERIAL CANNULADWFSubstantially EquivalentMedtronic Perfusion Systemsaccessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
April 22, 2025P240036OmniaSecure™ MRI SureScan™ Lead Model 3930MNVY7October 23, 2026accessdata.fda.gov
December 13, 2023P230017PulseSelect™ Pulsed Field Ablation (PFA) systemQZI11June 30, 2026accessdata.fda.gov
October 20, 2023P220012Aurora EV-ICD SystemLWS75July 31, 2026accessdata.fda.gov
October 21, 2020P200026Abre Venous Self-expanding Stent SystemQAN19October 16, 2026accessdata.fda.gov
April 28, 2017P160043RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMNIQ88October 16, 2026accessdata.fda.gov
April 6, 2016P150033MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMPNJ225September 8, 2026accessdata.fda.gov
April 27, 2015P120017MODEL 5071 LEADDTB40April 15, 2026accessdata.fda.gov
December 30, 2014P140010IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 PaclitaxONU97September 24, 2026accessdata.fda.gov
January 17, 2014P130021MEDTRONIC COREVALVE SYSTEMNPT182August 10, 2026accessdata.fda.gov
April 6, 2011P100018PIPELINE EMBOLIZATION DEVICEOUT51July 21, 2026accessdata.fda.gov
April 1, 2011P100040VALIANT THORACIC STENT GRAFT SYSTEMMIH69February 27, 2026accessdata.fda.gov
March 14, 2011P080025MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMQON349October 9, 2026accessdata.fda.gov
February 8, 2011P090013REVO MRI SURESCAN IPG AND PACING SYSTEMLWP325June 5, 2025accessdata.fda.gov
December 16, 2010P100021MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMMIH129May 12, 2026accessdata.fda.gov
April 7, 2009P080006MEDTRONIC ATTAIN ABILITY MODEL 4196 LEADOJX191June 24, 2026accessdata.fda.gov
June 13, 2008P060039ATTAIN STARFIX MODEL 4195 LEADOJX116February 10, 2026accessdata.fda.gov
August 3, 2005P030036MEDTRONIC SELECTSECURE LEAD MODEL 3830NVN159October 16, 2026accessdata.fda.gov
July 21, 2005P030004ONYX LIQUID EMBOLIC SYSTEMMFE41October 14, 2026accessdata.fda.gov
June 26, 2002P010031CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATIONNIK902October 5, 2026accessdata.fda.gov
August 28, 2001P010015MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMLWP574October 23, 2026accessdata.fda.gov
June 14, 2000P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOFLWS142April 15, 2026accessdata.fda.gov
January 29, 1999P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARENVZ822October 23, 2026accessdata.fda.gov
October 9, 1998P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORSLWS933October 5, 2026accessdata.fda.gov
September 29, 1997P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW448October 9, 2026accessdata.fda.gov
July 31, 1997P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMHY528October 6, 2026accessdata.fda.gov
September 6, 1996P950024MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695NVN114April 15, 2026accessdata.fda.gov
March 29, 1996P930039MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568NVN267June 24, 2026accessdata.fda.gov
December 9, 1993P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY294August 19, 2026accessdata.fda.gov
February 11, 1993P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS170April 15, 2026accessdata.fda.gov
August 24, 1989P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ459July 31, 2026accessdata.fda.gov
July 29, 1986P850089CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADSNVN167April 15, 2026accessdata.fda.gov
July 29, 1986P830061STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACINGNVN225June 24, 2026accessdata.fda.gov
November 30, 1984P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSLGW612October 6, 2026accessdata.fda.gov

Compare with other makers

Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.