Data / Medical devices / India / Medtronic Engineering and Innovation Center (MEIC)
Medtronic Engineering and Innovation Center (MEIC): FDA-registered device maker in Hyderabad Telangana, India, 1,317 510(k) clearances and 30 PMA approvals
Medtronic Engineering and Innovation Center (MEIC) is registered with the FDA (registration 3018094310) in Hyderabad Telangana, India. It lists 384 device types. The FDA files 1,317 510(k) clearances and 30 PMA approvals under its listings, the newest dated April 21, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3018094310
- Address
- BSR Tech Park Survey No.135, 138, 141 & 142 Nanakramguda Main Road, Hyderabad Telangana, India, 500032
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Complaint file establishment
- First device listed
- February 15, 1978
- Registered through
- 2027
- Brand names listed
- , MOTORS, 01-00XX Series, Drape, 1 X 8 Test Stimulation Lead, 3875 1 X 8 Subcompact Lead, 4070 Temp Monitor, 87410 Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (10mm), 87430 Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (3 mm ), 87435 Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (3.5 mm) and more
Devices it lists
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 1,317.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 21, 2026 | K260216 | CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| March 26, 2026 | K253379 | Stealth AXiS Cranial clinical application | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| March 16, 2026 | K253395 | Stealth AXiS ENT clinical application | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| February 10, 2026 | K251672 | NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080) | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| January 7, 2026 | K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 3, 2025 | K250725 | Hugo RAS System | SCV | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 11, 2025 | K251316 | Mazor X System / Mazor X Stealth Edition | OLO | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| August 7, 2025 | K251629 | UNiD Spine Analyzer | QIH | Substantially Equivalent | Medicrea International S.A.S. (Medtronic) | accessdata.fda.gov |
| June 5, 2025 | K242464 | Stealth Spine Clamps; ModuLeX Shank Mounts | OLO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| May 29, 2025 | K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | ONO | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| March 10, 2025 | K243676 | Duet External Drainage and Monitoring System (EDMS) | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| November 1, 2024 | K240881 | Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL) | GAG | Substantially Equivalent | Covidien (Part of Medtronic) | accessdata.fda.gov |
| October 28, 2024 | K241992 | Catalyft LS Expandable Interbody System | OVD | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 24, 2024 | K242034 | Duet External Drainage and Monitoring System (EDMS) | PCB | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| October 23, 2024 | K243007 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 6, 2024 | K241164 | IB3D PL Spinal System | MAX | Substantially Equivalent | Medicrea International S.A.S. (Medtronic) | accessdata.fda.gov |
| July 12, 2024 | K241085 | Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 1, 2024 | K240572 | Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 15 (4.6m) (VSMP15); Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab SM Smoke Management Extended Nozzle (for use with 4 (100mm) electrode) (VSMEN4); Valleylab SM Smoke Management Extended Nozzle (for use with 6.5 (165mm) electrode) (VSMEN6) | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| June 21, 2024 | K240465 | O-arm O2 Imaging System | OWB | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| May 20, 2024 | K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) | BTR | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| May 10, 2024 | K240276 | PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software | NEZ | Substantially Equivalent | Given Imaging Ltd. (D.B.A. Medtronic) | accessdata.fda.gov |
| March 27, 2024 | K233951 | CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| February 28, 2024 | K233830 | OsteoCool 2.0 RF Ablation System | GEI | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| October 27, 2023 | K231934 | GIA Stapler with Tri-Staple Technology | GAG | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 26, 2023 | K230320 | NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| October 19, 2023 | K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| September 8, 2023 | K231240 | MaxTack Motorized Fixation Device | OCW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 30, 2023 | K231580 | NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| August 16, 2023 | K232141 | CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 18, 2023 | K230716 | Robotic Graft Delivery Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| June 30, 2023 | K230991 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | NEZ | Substantially Equivalent | Given Imaging Ltd. (Medtronic) | accessdata.fda.gov |
| May 26, 2023 | K231184 | CD Horizon Spinal System | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 7, 2023 | K230064 | Mazor X System (Mazor X Stealth Edition) | OLO | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| February 22, 2023 | K221629 | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) | GAG | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 23, 2023 | K223494 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| January 23, 2023 | K223158 | LigaSure XP Maryland Jaw Sealer/Divider | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 2, 2022 | K223218 | Parietene Macroporous Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| November 30, 2022 | K221771 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 29, 2022 | K222641 | Signia Small Diameter Reloads Including Regular (Round) Tip Version | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 29, 2022 | K222383 | Anteralign LS Spinal System with Titan nanoLOCK Surface Technology MAZORX Stealth(TM) Edition | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 22, 2022 | K220540 | ProGrip Self-Gripping Polypropylene Mesh | FTL | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 27, 2022 | K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 22, 2022 | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| June 13, 2022 | DEN220006 | ProdiGI | QSW | Unknown | Covidien, LLC | accessdata.fda.gov |
| June 10, 2022 | K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| May 25, 2022 | K221244 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 25, 2022 | K221180 | Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| May 5, 2022 | K221013 | GIA Auto Suture Stapler with DST Series Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 29, 2022 | K221006 | GIA Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 19, 2022 | K220810 | Infinity OCT System and PASS OCT Spinal System | NKG | Substantially Equivalent | Medicrea International | accessdata.fda.gov |
| April 18, 2022 | K220131 | KYPHON VuE Bone Cement | NDN | Substantially Equivalent | Tecres S.P.A. | accessdata.fda.gov |
| April 12, 2022 | K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA | accessdata.fda.gov |
| April 8, 2022 | K220724 | CD Horizon Spinal System and PASS LP Spinal System | NKB | Substantially Equivalent | Medicrea International | accessdata.fda.gov |
| March 21, 2022 | K213246 | NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long | ETN | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| February 25, 2022 | K203150 | Cool-tip RF Ablation System E Series | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| February 9, 2022 | K214011 | Catalyft PL Expandable Interbody System Navigated Instruments, Anteralign TL Spinal System with Titan nanoLOCK Surface Technology Navigated Instruments, and CD Horizon Solera Voyager Spinal System Navigated, Guided, and Powered Drivers | OLO | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 12, 2022 | K212005 | UNiD Spine Analyzer | LLZ | Substantially Equivalent | Medicrea International, Inc. | accessdata.fda.gov |
| January 7, 2022 | K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | ONO | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| January 5, 2022 | K213281 | PASS LP Spinal System, CD Horizon Spinal System | NKB | Substantially Equivalent | Medicrea International SA | accessdata.fda.gov |
| December 22, 2021 | K212397 | StealthStation S8 Cranial v2.0 | HAW | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| December 13, 2021 | K212428 | Centerpiece Plate Fixation System | NQW | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| December 8, 2021 | K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| December 5, 2021 | K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) | MUD | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 23, 2021 | K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm | HBE | Substantially Equivalent | Medtronic Powered Surgical Solutions | accessdata.fda.gov |
| November 22, 2021 | K210265 | VS3 Iridium Sytem | OWN | Substantially Equivalent | Visionsense, Ltd. | accessdata.fda.gov |
| November 19, 2021 | K212653 | Catalyft LS Expandable Interbody System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| November 15, 2021 | K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | LFL | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 16, 2021 | K212641 | StrataMR II Valves and Shunts | JXG | Substantially Equivalent | Medtronic Neurosurgery | accessdata.fda.gov |
| September 3, 2021 | K210470 | C-CURVE Interbody Fusion Device | OVE | Substantially Equivalent | Medicrea International SA | accessdata.fda.gov |
| August 27, 2021 | K211684 | PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E | NEZ | Substantially Equivalent | Given Imaging Ltd. (Medtronic) | accessdata.fda.gov |
| August 23, 2021 | DEN210003 | SureTune4 Software | QQC | Unknown | Medtronic Neuromodulation | accessdata.fda.gov |
| August 16, 2021 | K210841 | NuVent Eustachian Tube Dilation Balloon | PNZ | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| July 21, 2021 | K211958 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| July 8, 2021 | K211442 | StealthStation Spinous Process Clamps | OLO | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| June 23, 2021 | K211596 | CD Horizon Spinal System | OLO | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| May 24, 2021 | K210425 | Catalyft PL Expandable Interbody System | MAX | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| April 30, 2021 | K210637 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| April 15, 2021 | K210338 | Edge Insulated Blade Electrode | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 23, 2021 | K202917 | LigaSure Exact Dissector, Nano-coated | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| January 21, 2021 | K202507 | EEA Circular Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 15, 2021 | K203678 | CD HORIZON Spinal System | NQP | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| January 13, 2021 | K203639 | StealthStation Cranial Software v1.3.2 | HAW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
| January 9, 2021 | K202874 | Puritan Bennett Cuff Pressure Manager | BSK | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 8, 2020 | K202623 | Novapak Nasal Sinus Packing and Stent | LYA | Substantially Equivalent | Medtronic Xomed | accessdata.fda.gov |
| December 7, 2020 | K202701 | GIA Stapler with Tri-Staple Technology | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| November 20, 2020 | K193056 | Puritan Bennett 980 Series Ventilator System | CBK | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| November 2, 2020 | K202552 | Midas Rex Attachments and Dissecting Tools | OLO | Substantially Equivalent | Medtronic Powered Surgical Solutions (Mpss) | accessdata.fda.gov |
| October 28, 2020 | K202864 | Tri-Staple 2.0 Reloads | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 28, 2020 | K200759 | NIM Vital, Nerve Integrity Monitor | GWF | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| October 27, 2020 | K203005 | Mazor X | OLO | Substantially Equivalent | Mazor Robotics , Ltd. | accessdata.fda.gov |
| September 10, 2020 | K201407 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| September 8, 2020 | K202328 | CD Horizon Spinal System | NKB | Substantially Equivalent | Medtronic Sofamor Danek USA, Inc. | accessdata.fda.gov |
| August 26, 2020 | K201805 | VersaOne Reusable Positioning Trocar System | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| August 26, 2020 | K201267 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | MAX | Substantially Equivalent | Medtronic Sofamor Danek | accessdata.fda.gov |
| August 26, 2020 | K200796 | Emprint Ablation System with Thermosphere Technology | NEY | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| August 19, 2020 | K201362 | CD Horizon Fenestrated Screw Set, CD Horizon Spinal System, Kyphon HV-R Bone Cement | PML | Substantially Equivalent | Medtronic | accessdata.fda.gov |
| July 20, 2020 | K201179 | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable | DQA | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| July 17, 2020 | K201672 | Signia Stapler (with new software) | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 10, 2020 | K200427 | Sonicision Cordless Ultrasonic Dissector | LFL | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| June 26, 2020 | K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | PGW | Substantially Equivalent | Medtronic Navigation, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 18, 2025 | P240011 | Medtronic Altaviva System | QPT | 15 | September 14, 2026 | accessdata.fda.gov |
| October 20, 2023 | P220012 | Aurora EV-ICD System | LWS | 75 | July 31, 2026 | accessdata.fda.gov |
| July 24, 2014 | P090029 | PRESTIGE LP CERVICAL DISC | MJO | 20 | August 9, 2024 | accessdata.fda.gov |
| March 14, 2011 | P080025 | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM | QON | 349 | October 9, 2026 | accessdata.fda.gov |
| February 8, 2011 | P090013 | REVO MRI SURESCAN IPG AND PACING SYSTEM | LWP | 325 | June 5, 2025 | accessdata.fda.gov |
| September 4, 2009 | P080013 | DURASEAL EXACT SPINE SEALANT SYSTEM | NQR | 28 | February 27, 2026 | accessdata.fda.gov |
| May 12, 2009 | P060023 | BRYAN CERVICAL DISC PROSTHESIS | MJO | 7 | March 18, 2020 | accessdata.fda.gov |
| April 7, 2009 | P080006 | MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD | OJX | 191 | June 24, 2026 | accessdata.fda.gov |
| July 16, 2007 | P060018 | PRESTIGE CERVICAL DISC SYSTEM | MJO | 5 | August 11, 2016 | accessdata.fda.gov |
| March 9, 2007 | P050053 | INFUSE BONE GRAFT | NPZ | 63 | August 26, 2026 | accessdata.fda.gov |
| November 21, 2005 | P040001 | X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM | NQO | 19 | December 12, 2014 | accessdata.fda.gov |
| August 3, 2005 | P030036 | MEDTRONIC SELECTSECURE LEAD MODEL 3830 | NVN | 159 | October 16, 2026 | accessdata.fda.gov |
| April 7, 2005 | P040034 | DURASEAL DURAL SEALANT SYSTEM | NQR | 38 | February 27, 2026 | accessdata.fda.gov |
| April 30, 2004 | P000054 | INFUSE BONE GRAFT | MPW | 72 | August 26, 2026 | accessdata.fda.gov |
| July 2, 2002 | P000058 | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE | NEK | 90 | August 26, 2026 | accessdata.fda.gov |
| June 26, 2002 | P010031 | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION | NIK | 902 | October 5, 2026 | accessdata.fda.gov |
| June 13, 2002 | P000028 | AFFINITY (TM) CAGE SYSTEM | MAX | 7 | July 25, 2006 | accessdata.fda.gov |
| May 22, 2002 | P010002 | INDERMIL(TM) TISSUE ADHESIVE | MPN | 4 | November 12, 2003 | accessdata.fda.gov |
| August 28, 2001 | P010015 | MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM | LWP | 574 | October 23, 2026 | accessdata.fda.gov |
| July 21, 2000 | P990034 | MEDTRONIC ISOMED INFUSION SYSTEM | LKK | 36 | November 22, 2024 | accessdata.fda.gov |
| May 14, 1999 | P970015 | INTER FIX THREADED FUSION DEVICE | MAX | 22 | July 27, 2005 | accessdata.fda.gov |
| October 9, 1998 | P980016 | VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS | LWS | 933 | October 5, 2026 | accessdata.fda.gov |
| September 29, 1997 | P970004 | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL | EZW | 448 | October 9, 2026 | accessdata.fda.gov |
| July 31, 1997 | P960009 | MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM | MHY | 528 | October 6, 2026 | accessdata.fda.gov |
| March 29, 1996 | P930039 | MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 | NVN | 267 | June 24, 2026 | accessdata.fda.gov |
| December 9, 1993 | P920015 | MEDTRONIC(R) TRANSVENE LEAD SYSTEM | NVY | 294 | August 19, 2026 | accessdata.fda.gov |
| August 24, 1989 | P890003 | SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 | NVZ | 459 | July 31, 2026 | accessdata.fda.gov |
| March 14, 1988 | P860004 | MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM | LKK | 442 | October 16, 2026 | accessdata.fda.gov |
| July 29, 1986 | P830061 | STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING | NVN | 225 | June 24, 2026 | accessdata.fda.gov |
| November 30, 1984 | P840001 | ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS | LGW | 612 | October 6, 2026 | accessdata.fda.gov |
Compare with other makers
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Updated September 14, 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.