Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009380063

FEI Number

3009380063

Entity Name

Medtronic Distribution Center

City/State/Country

Memphis, TN, US

Establishment Address

5300 Airways Blvd, Memphis, TN 38116, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143107

PMA Number

N/A

All Registered Proprietary Names

DLP Cannula Attain StarFix PCD End Cap GEM Patient Cable Lead Patch MICRO JEWEL Patient Magnet MICRO JEWEL II Ace Header Emulator Epicardial Patch Lead Upsizing Sleeve Sizing Sleeve GEM VR Endoskeleton TCS Interbody Fusion Device Versastep MC2 Multistage Reveal LINQ LigaSure Retractable L-Hook Laparoscopic Sealer/Divider, LF5637 and LF5644 Axium Detachable Coil System spinal system Cannula AUTOSUTURE ENDOSCOPIC CLAMP Tri-staple 2 Reinforced Reload Gundry RSCP Valleylab Button Switch Pencil Needle Electrode, Holster, E2516HDA Valleylab Rocker Switch Pencil Needle Electrode, Holster, E2515HDA and E2515HDANSB Electrodes Valleylab Rocker Switch Pencil Holster, E2515H, E2515HDB, E2515HDBNSB, E2515HGNSB, and E2515HNSB Valleylab Button Switch Pencil, E2516, E2516GNSB, and E2516NSB Valleylab Rocker Switch Pencil, E2515, E2515NSB, and E2515GNSB Valleylab Button Switch Pencil Holster, E2516H, E2516HGNSB, and E2516HNSB Advisa DR MRI SureScan Advisa DR Adapta InCheck Patient Assistant Relia IPG Adapta L Adapta S Advisa SR MRI SureScan Versa DR IPG Sensia DR IPG Azure XT DR MRI Azure S SR MRI Azure XT SR MRI Azure S DR MRI CareLink SmartSync Azure Astra Application Sphera DR MRI Attesta L DR MRI Attesta SR MRI Attesta S DR MRI Attesta DR MRI Sphera SR MRI Sphera L DR MRI Sensia IPG Valiant Thoracic Stent Graft System Abre Venous Self-expanding Stent System ARTiC-L 3D Ti Spinal System with TiONIC Technology Catalyft LS Expandable Interbody System Impulse II Lead CapSure SP Novus CapSure Z Novus stylet kit In.Pact Admiral Paclitaxel-Coated PTA Balloon Catheter In.Pact 018 Paclitaxel-Coated PTA Balloon Catheter One Step Cannula ENDO SHEARS Bluntport Signature DLP Pressure Monitoring Catheter InterStim II Neurostimulator InterStim Neurostimulator Verify Controller Verify Evaluation System InterStim Sacral Nerve Stimulation InterStim iCon Patient Programmer Verify External Neurostimulator InterStim II Sacral Nerve Stim N'Vision Software Application Card N'Vision Programmer InterStim Micro Implantable Neurostimulator InterStim SureScan MRI leads InterStim X Implantable Neurostimulator Bio-Medicus Cannula Reliant Stent Graft Balloon Catheter MULTIPLE (ORTHOPEDIC REAMERS) CD Horizon ModuLeX LigaMAS Head Assm Parietex Hydrophilic 2-Dimensional Mesh Reveal LINQ Insertion Tools REVEAL LINQ OmniaSecure MRI SureScan Capsure SP Novus Vitatron Crystalline Lead CapSure Sense Adhesive Vitatron Excellence PS+ Lead stylet kit CapSure Unipolar Lead CapSure Sense MRI SureScan Leads RIALTO" SI FUSION SYSTEM CapSure Epicardial Pacing lead EEA TAID Guide Pin; Introducer Tool DRILL GUIDES GUIDE WIRES (PINS) LAA Selection Guide Concerto Detachable Coil System Versaport Bladeless Optical Trocar DLP Cannula EOPA 3D InterStim II Neurostimulator Verify External Neurostimulator InterStim Therapy System Verify Controller Verify Evaluation System N'Vision Software Application Card InterStim iCon Programmer N'Vision Programmer InterStim Micro Implantable Neurostimulator InterStim SureScan MRI leads InterStim X Implantable Neurostimulator Cannula Solitaire Platinum Revascularization Device DLP Aortic Root Cannula VersaOne Bladed and Bladeless Trocars Solitaire Platinum Revascularization Device Versaport V2 Bladeless Optical Trocar Heli-FX Thoracic EndoAnchor System Versaport RPF PROBE (ORTHOPEDIC MANU CD Horizon ModuLeX Spinal System Heli-FX EndoAnchor System CD HORIZON Spinal System Lead anchoring Sleeve SELECTSECURE SelectSecure MRI SureScan Clearify Medtronic Reusable Instrument Sonicision Curved Jaw Cordless Ultrasonic Dissector 5 mm 39 cm, SCDA39 Sonicision Curved Jaw Cordless Ultrasonic Dissector 5 mm 48 cm, SCDA48 Sonicision Battery Charger, CBCA Sonicision Reusable Generator, SCGAA Sonicision Reusable Battery Insertion Guide, SCBIGA Sonicision Curved Jaw Cordless Ultrasonic Dissector 5 mm 13 cm, SCDA13 Sonicision Curved Jaw Cordless Ultrasonic Dissector 5 mm 26 cm, SCDA26 Sonicision Reusable Battery Pack, SCBA General Instruments Micra Transcatheter Pacemaker System Micra TPS Micra AV TPS Micra AV2 TPS Micra VR2 TPS BIOPUMP (VARIOUS MODELS) VERSAPORT VERSASEAL ArthroPort CD Horizon ModuLeX Fenestrated Screw Set CD Horizon ModuLeX Spinal System CD HORIZON Spinal System Analyzer Adapter Prodigy IPG Medtronic CareLink Monitor Service Kit Adapter Cable Sterile Plastic Sleeve CapSure Lead CareLink Express Mobile System - Android CapSure VDD-2 Lead CareLink Express Monitor ECG Port Plug ECG Output Adapter CareLink Wireless Network Adapter Card Program Interface Cable CareLink Express Mobile System - iOS CareLink Encore Programmer Analyzer Cable ECG Cable Lead Analyzer MyCareLink Patient Monitor CardioSight Reader CareLink Encore Programmer RF Head CareLink Programmer RF Head Medtronic CareLink Programmer CareLink SmartSync Power Cord 249705 CareLink SmartSync Patient Connector 24967 CareLink SmartSync Base 24970A CareLink SmartSync PSA Application CareLink SmartSync Common Application iOS CareLink SmartSync Power Supply 249701 Integrated Diagnostics Data Calculation Module Model 5242 Instrument Command Library (ICL)Device Command Library (DCL) MULTIPLE TWIST Drill; Introducer Tool MICRO-FRANCE BIT DRILLS DRILL BIT (ORTHOPEDIC MA Visiport V-Loc Reloads LINQ Tool Kit LINQ II Insertable Cardiac Monitor Polysorb Navigated CD HORIZON SOLERA Screwdrivers and Taps CD HORIZON SOLERA Spinal System Liberant Thrombectomy System Heli-FX EndoAnchor System Doubletime Trocar Heli-FX EndoAnchor System Viva Quad S CRT-D Claria MRI Quad CRT-D Amplia MRI CRT-D SureScan Concerto II CRT-D Viva S CRT-D Consulta ICD Brava Viva Maximo II CRT-D Protecta XT CRT-D Brava Quadripolar CRT-D Viva Quad XT CRT-D Protecta CRT-D Consulta DF4 ICD Compia MRI Quad CRT-D SureScan Compia MRI CRT-D SureScan Viva XT CRT-D Amplia MRI Quad CRT-D SureScan Concerto ICD Claria MRI CRT-D Crome HF CRT-D MRI SureScan Crome HF Quad CRT-D MRI SureScan Cobalt XT HF Quad CRT-D MRI SureScan Cobalt HF Quad CRT-D MRI SureScan Cobalt XT HF CRT-D MRI SureScan Cobalt HF CRT-D MRI SureScan Edge Insulated Needle Electrode, Safety Sleeve, (4", (10.16 cm), E1465B-4 Edge Pencil Blade Electrode, Holster, E2250H Edge Insulated Needle Electrode, 6.5" (16.51 cm), E1465-6 Edge Button Switch Pencil Blade Electrode, Holster, E2450HDBNSB Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HDBNSB Edge Blade Electrode, (6.5" (, 16.51 cm), E1450-6 and E1450-6NSB Edge Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HS Edge Insulated Blade Electrode, Safety Sleeve, (4" (, 10.16 cm), E1455B4 Edge Insulated Blade Electrode, Safety Sleeve, (4", (10.16 cm), E1455B-4NSB Edge Insulated Needle Electrode, (2.8", (7.2 cm), E1465NSB Edge Needle Electrode, (2.8", (7.2 cm), E1452NSB Edge Rocker Switch Pencil Blade Electrode, Holster, E2350H Edge Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HSNSB Edge Hex-locking Blade Electrode, (2.5 (, 6.35 cm), E1450X and E1450XNSB Edge Button Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2450HS Edge Pencil Blade Electrode, Holster, E2250HNSB Edge Needle Electrode, (6.5" (, 16.51 cm), E1452-6 Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HDB Edge Button Switch Pencil Blade Electrode, Holster, E2450H Valleylab Insulated Micro-Needle Electrode, 9 cm, E1654B Edge Insulated Needle Electrode, Safety Sleeve, (2.8", (7.2 cm), E1465B and E1465BNSB Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HNSB Micro-Needle Electrodes, E16XX Valleylab Straight Micro-Needle Electrode, 3 cm, E1651 Edge Insulated Blade Electrode, Safety Sleeve, (2.75", (7 cm), E1455BNSB Edge Insulated Blade Electrode, (6.5", (16.51 cm), E1455-6 and E1455-6NSB Edge Blade Electrode, (4", (10.16 cm), E1450-NSB Edge Coated Blade Extended Electrode, ( 4" , (10.16 cm), E1450-4 Edge Insulated Needle Electrode, (2.8", (7.2 cm), E1465 Edge Needle Electrode, (2.8" (, 7.2 cm), E1452 Edge Insulated Blade Electrode, Safety Sleeve (2.75", (7 cm), E1455NSB Valleylab Angled Micro-Needle Electrode, 45 degree, 1 cm from tip, 3 cm, E1653 Edge Insulated Blade Electrode, Safety Sleeve, (2.75" (, 7 cm), E1455B Valleylab Angled Micro-Needle Electrode, 45 degree, 3 mm from tip, 3 cm, E1652 Edge Insulated Blade Electrode, (4", (10.16 cm), E1455-4 and E1455-4NSB Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HGNSB Edge Insulated Blade Electrode, (2.75", (7 cm), E1455 Coated Electrodes Valleylab Straight Micro-Needle Electrode, 2 cm, E1650 Edge Button Switch Pencil Blade Electrode, Holster, E2450HNSB Edge Button Switch Pencil Blade Electrode, Holster, E2450HGNSB Edge Blade Electrode, (3 (, 7.62 cm), E1450G and E1450GNSB SurgiTie Valleylab Smoke Evacuation Pencil, Sterile, CVPLP2000 DLP Cannula Attain Ability Lead Attain Performa MRI SureScan Lead Attain Performa S MRI SureScan Lead Attain Performa S Lead Attain Ability MRI SureScan Lead Attain Ability Straight Lead Attain Performa Straight MRI SureScan Lead Attain Ability Straight MRI SureScan Lead Attain Performa Straight Lead Attain Ability Plus Lead Attain Performa Lead Attain Ability Plus MRI SureScan Lead Attain Stability Quad MRI SureScan Lead Solitaire Platinum Revascularization Device Versaport Bladeless PDB ProGrip Laparoscopic Self-Fixating Mesh MONITOR TEMPERATURE ENDO CLOSE Soveriegn Spinal System Axium Detachable Coil System Medtronic Reusable Instrument Heli-FX EndoAnchor System INFINITY Occipitocervical Upper Thoracic System OptiMumm Smoke Reducer Fitting, E3655 OptiMumm Smoke Sponge Guard Tubing, E3635 RapidVac Tubing, SEA3705 OptiMumm ULPA Filter, E3625 OptiMumm Smoke Prefilter, E3630 RapidVac Tubing, SEA3710 RapidVac Tubing with Sponge Guard, SEA3715 OptiMumm Smoke Prefilter Reducer Adapter, E3660 OptiMumm Smoke Prefilter Reducer Adapter, E3665 OptiMumm Smoke Tubing, E3645 RapidVac Laparoscopic Tubing, SEA3720 RapidVac Wand, Laser Resistant, SEA3725 Robotic Graft Delivery Instruments DLP Silicone RCSP Cannula Cannula ENDO GIA ROTICULATOR Staplers RCSP Tri-Staple 2 Intelligent Cartridges CoreValve Evolut PRO System Medtronic CoreValve System CoreValve Evolut R System CoreValve Evolut PRO+ System Evolut FX+ System Medtronic Evolut FX System Heli-FX EndoAnchor System MAST QUADRANT Retractor System Autolog Autotransfusion Cannula LigaSure Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Nano-coated, LF1937 and LF1944 LigaSure Maryland Jaw Open Sealer/Divider One-step Sealing, Nano-coated, LF1923 VersaOne Bladeless and Optical 15mm Endo Clip III Cannula EEA Surgical Stapler Pipeline Flex Embolization Device with Shield Technology Pipeline Flex with Shield Technology Pipeline Flex Embolization Device Pipeline Vantage Embolization Device with Shield Technology Medtronic Reusable Instrument Adaptor Extender Kit Sprint Quattro Secure MRI SureScan Lead DF-1 Port Pin Plug Subcutaneous Lead Tunneling Tool Sprint Quattro Secure S MRI SureScan Lead Sprint Quattro Secure S Lead Sprint Quattro MRI SureScan Lead Sprint Quattro Lead Transvene Lead Transvene SVC Lead Adaptor Kit IS-1 Port Pin Plug Kit Sprint Quattro Secure Lead MULTIPLE (DRIVER-EXTRACTORS) IB3D PL Spinal System MULTIPLE (ORTHOPEDIC OSTEOTOMES) Solitaire Platinum Revascularization Device Solitaire Platinum Revascularization Device Myocardial Pacing Lead Valleylab REM Polyhesive Adult Cordless Patient Return Electrode, E7508 Valleylab REM Polyhesive Adult Patient Return Electrode, E7507DB Valleylab Non-REM Polyhesive Patient Return Electrode, E7506 Valleylab REM Polyhesive Adult Patient Return Electrode, E7507 Polyhesive Patient Return Electrode ENDO PADDLE RETRACT CD Horizon ModuLeX FNS Screw Set CD Horizon ModuLeX Spinal System Absorbatack STAT Tack Tacker System Protack Laparoscopic Handswitch/Electrodes DLP Cannula V-Loc Appose Skin Staplers Signet ConcordeMultifire Premium skin stapler SFS Stapler McKesson Skin Staplers 35 WIDE McKesson Skin Staplers 35 REGULAR CD Horizon ModuLeX Spinal System Navien Intracranial Support Catheter CD HORIZON® Fenestrated Screw Set KYPHON Cement Delivery System KyphX Bone Filler Device Axium Prime Detachable Coil System (FitzRoy) EEA OrVil Laparoscope ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT Expandable Cage Wave O Spinal System E3773-45C, CleanCoat Laparoscopic Wire L-Hook Electrode , Coated, 45cm E3774-45, Valleylab Laparoscopic Flat L-Hook Electrode, Solid, 45cm E3771-36C, CleanCoat Laparoscopic Curved Spatula Electrode, Coated, 36cm E3773-45, Valleylab Laparoscopic Wire L-Hook Electrode, Solid, 45cm E3772-36, Valleylab Laparoscopic Wire J-Hook Electrode, Solid, 36cm E3772-36C, CleanCoat Laparoscopic Wire J-Hook Electrode, Coated, 36cm E3774-36C, CleanCoat Laparoscopic Flat L-Hook Electrode, Coated, 36cm E3771-45C, CleanCoat Laparoscopic Curved Spatula Electrode, Coated, 45cm E3771-36, Valleylab Laparoscopic Curved Spatula Electrode, Solid, 36cm E3773-36, Valleylab Laparoscopic Wire L-Hook Electrode, Solid, 36cm E3773-36C, CleanCoat Laparoscopic Wire L-Hook Electrode Coated, 36cm E3770-36C, CleanCoat Laparoscopic Straight Spatula Electrode Coated, 36cm E3771-45, Valleylab Laparoscopic Curved Spatula Electrode, Solid, 45cm E3770-36, Valleylab Laparoscopic Straight Spatula Electrode, Solid, 36cm E3774-36, Valleylab Laparoscopic Flat L-Hook Electrode, Solid, 36cm E3774-45C, CleanCoat Laparoscopic Flat L-Hook Electrode, Coated, 45cm ProGrip Self-Gripping Polyester Mesh MULTIPLE (DEPTH GAUGES) Tissue Approximating Forceps FORCEPS (MANUAL INSTRU MULTIPLE FORCEPS Blunt Tip Trocars INFINITY Occipitocervical Upper Thoracic System Versastep V2 Heli-FX EndoAnchor System Adapter SELECT RETRACTOR RadiaLux Spacekeeper Orion Micro Catheter Bio-Medicus Cannula Endurant II AUI Stent Graft System Endurant Stent Graft System Endurant IIs Stent Graft System Endurant II Stent Graft System Talent Occluder with Occluder Delivery System ENDO STITCH ProGrip Laparoscopic Self-Fixating Mesh Riptide Large Bore Aspiration Tubing Endo GIA Pancreas Indication LigaSure Exact Dissector Nano-coated, LF2019 LigaSure Blunt Tip Open Sealer/Divider Nano-coated, LF1823 LigaSure Blunt Tip, Laparoscopic Sealer/Divider Nano-coated, LF1837 and LF1844 SURGINEEDLE Surgiclip" PrimeAdvanced SureScan MRI Neurostimulator Injex Bumpy Anchor Pisces-Quad Plus Lead N'Vision Software Application Card Specify SureScan MRI Lead Pisces-Quad Compact Lead Resume II Lead RestoreUltra SureScan MRI Neurostimulator Itrel 4 Neurostimulator Resume TL Lead Titan Anchor RestoreSensor Neurostimulator Itrel 4 Neurostimulation System Stretch Coil Extension RestoreAdvanced Neurostimulator EZ Anchor Injex BiWing Anchor RestoreAdvanced SureScan MRI Neurostimulator Specify Lead Vectris SureScan Lead RestorePrime Neurostimulator Itrel EZ Programmer Synergy EZ Programmer RestoreUltra Neurostimulator RestoreSensor SureScan MRI Neurostimulator PrimeAdvanced Neurostimulator myStim Programmer N'Vision Programmer Intellis with AdaptiveStim Implantable Neurostimulator Vanta with AdaptiveStim Implantable Neurostimulator Inceptiv LT Implantable Neurostimulator Inceptiv Implantable Neurostimulator Intellis Pro Implantable Neurostimulator Myocardial Pacing Lead DLP Cannula CD Horizon ModuLeX Spinal System Solitaire X Revascularization Device SCREWDRIVER ProStream Sidehole Infusion Wire Access Review Therapy Controller Activa PC Neurostimulator N'Vision Programmer Activa SC Neurostimulator DBS Therapy for Dystonia N'Vision Software Application Card DBS Extension Kit StimLoc Activa Dystonia Therapy Percept PC BrainSense SenSight DLP Cannula

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2011-05-25
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Unknown	Class 3	N/A	2011-05-25
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2009-06-24
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2019-09-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2017-02-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-01
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2014-02-03
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2014-02-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2012-09-24
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2023-01-31
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2023-02-06
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-02-06
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-02
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2007-01-24
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-01-24
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2007-01-24
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-01-24
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2007-01-24
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2011-04-12
QAN	Stent, Iliac Vein	Unknown	Class 3	N/A	2020-10-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-10-09
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-11-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-11-14
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2010-07-15
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2010-07-15
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2010-07-15
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2014-12-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-01-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
EZW	Stimulator, Electrical, Implantable, For Incontinence	Gastroenterology, Urology	Class 3	876.5270	2007-12-26
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-12-07
HTO	Reamer	Orthopedic	Class 1	888.4540	2005-05-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-12
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2026-01-12
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-12
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-30
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2014-02-18
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2025-05-28
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2008-03-12
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2008-03-12
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2008-03-12
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2016-02-26
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2011-05-26
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2011-05-26
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2011-05-26
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2005-05-31
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2009-03-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
QON	Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	Gastroenterology, Urology	Class 3	876.5270	2011-04-21
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2019-07-12
POL	Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	Neurology	Class 2	882.5600	2019-07-12
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2017-03-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
OTD	Endovascular Suturing System	Cardiovascular	Class 2	870.3460	2015-07-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
HXB	Probe	Orthopedic	Class 1	888.4540	2006-06-29
OTD	Endovascular Suturing System	Cardiovascular	Class 2	870.3460	2015-07-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-07-18
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-07-18
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-07-18
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2012-07-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-07-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-07-18
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2007-01-22
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2007-01-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
OCT	Anti Fog Solution And Accessories, Endoscopy	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
HWJ	Awl	Orthopedic	Class 1	888.4540	2002-11-19
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2023-02-02
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-09-09
PNJ	Leadless Pacemaker	Cardiovascular	Class 3	870.3610	2016-04-07
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2016-04-07
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2000-06-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-05-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-05-05
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-05-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2012-09-20
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2012-09-20
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2012-09-20
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2012-09-20
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2012-09-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2012-09-20
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2007-01-24
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2007-01-24
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-01-24
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2007-01-24
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2007-01-24
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-01-24
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2006-06-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-02-03
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-02-03
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2023-02-03
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2020-07-08
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2023-01-30
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2014-06-05
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2014-06-05
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2025-06-24
OTD	Endovascular Suturing System	Cardiovascular	Class 2	870.3460	2018-11-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
OTD	Endovascular Suturing System	Cardiovascular	Class 2	870.3460	2015-07-26
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2002-11-22
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2002-11-22
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2002-11-22
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2002-11-22
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2002-11-22
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2002-11-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-03
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2023-01-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-01
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Unknown	Class 3	N/A	2010-08-04
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2016-12-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2023-01-31
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-30
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2008-03-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2012-08-02
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2015-08-13
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2015-08-13
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	1992-12-12
OTD	Endovascular Suturing System	Cardiovascular	Class 2	870.3460	2017-06-23
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-02-03
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-02-03
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-02-03
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2023-02-02
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-07-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-01-31
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-02-06
NPT	Aortic Valve, Prosthesis, Percutaneously Delivered	Unknown	Class 3	N/A	2014-01-17
OTD	Endovascular Suturing System	Cardiovascular	Class 2	870.3460	2015-07-26
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2008-02-04
FSZ	Light, Surgical, Carrier	General, Plastic Surgery	Class 2	878.4580	2008-02-04
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2008-02-04
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2023-01-30
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2023-01-30
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-01-31
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-01-31
OUT	Intracranial Aneurysm Flow Diverter	Unknown	Class 3	N/A	2011-12-08
HXW	Bender	Orthopedic	Class 1	888.4540	1992-12-12
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2008-03-12
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2008-03-12
HWB	Extractor	Orthopedic	Class 1	888.4540	2005-05-31
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2005-05-31
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2016-01-13
POL	Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	Neurology	Class 2	882.5600	2019-02-20
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2019-02-20
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2015-05-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-02
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2023-01-31
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2024-02-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-02-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-02-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-01-31
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-01-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-02
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2023-02-03
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2023-01-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-06-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-06-07
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-06-07
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2022-06-07
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-06-07
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2012-01-23
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2008-02-27
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2017-01-24
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2017-01-24
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-02-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-31
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2007-03-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-06-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-01
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-30
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2005-05-31
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2006-06-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-02-19
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2026-02-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2023-01-30
OTD	Endovascular Suturing System	Cardiovascular	Class 2	870.3460	2015-07-26
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2005-03-23
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-07-23
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-03-14
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2010-12-22
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2023-01-30
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2023-01-30
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2018-12-19
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-01-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-02-01
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2023-01-31
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2023-01-30
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2007-12-06
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2007-12-06
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2013-04-12
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-06-12
POL	Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	Neurology	Class 2	882.5600	2021-03-01
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2021-03-01
HXX	Screwdriver	Orthopedic	Class 1	888.4540	1992-12-12
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-07-23
MRU	Implanted Subcortical Electrical Stimulator (Motor Disorders)	Unknown	Class f	N/A	2008-06-09
OLM	Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)	Unknown	Class f	N/A	2008-06-09
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2015-01-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

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Medtronic, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Z-0002-2007	Guidant Corporation	3	Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Z-0003-2018	St Jude Medical Inc.	3	Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
Z-0037-2012	Boston Scientific CRM Corp	3	LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493. When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009380063. Last updated year: 2026. Please use registration number 3009380063 when referencing this establishment in official correspondence.