Medtronic, Inc.
FDA 510(k) medical device clearances.
Top product codes for Medtronic, Inc.
Recent clearances by Medtronic, Inc.
1–100 of 210- K261866 — Concerto Versa Detachable Coil
- K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
- K253203 — Retrograde Coronary Sinus Perfusion Cannulae
- K253998 — Clearview Intracoronary Shunts
- K251831 — Bio-Medicus Life Support Catheter and Introducer
- K253511 — Concerto Versa Detachable Coil
- K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
- K251258 — MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula
- K250075 — Medtronic Stedi Extra Support Guidewire
- K250199 — VitalFlow Console
- K250558 — SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
- K242705 — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
- K243892 — Affera Integrated Mapping System
- K243435 — Magnetic Localization Patch Kit (AFR-00021)
- K241828 — Affera Integrated Mapping System; Impedance Localization Patch Kit
- K240880 — VitalFlow Set with Balance Biosurface
- K241352 — Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)
- K241259 — Amplatz Goose Neck Snare Kit
- K240534 — Bio-Medicus Life Support Catheter and Introducer
- K233838 — Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint Ablation Generator (CAGEN1); Emprint Ablation Generator HP (CAGENHP); Emprint Ablation Pump (CAPUMP1); Covidien Ablation Footswitch (RFASW); Emprint Reinforced Percutaneous Antenna 15cm (CA15L2); Emprint Reinforced Percutaneous Antenna 20cm (CA20L2); Emprint Reinforced Percutaneous Antenna 30cm (CA30L2); Covidien Remote Temperature Probe (RTP20); Covidien Remote Temperature Probe, Bulk (RTP20B)
- K240693 — LINQ II Insertable Cardiac Monitor (ICM)
- K233943 — Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
- K231206 — DLP Silicone Coronary Artery Ostial Cannulae
- K233562 — LINQ II Insertable Cardiac Monitor
- K233397 — Cosine-10TM Diagnostic Catheter
- K232321 — FlexCath Contour Steerable Sheath
- K233320 — LINQ II Insertable Cardiac Monitor (LNQ22)
- K230960 — DLP Silicone Coronary Artery Ostial Cannulae
- K230553 — LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
- K223168 — Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface
- K230640 — Affinity Fusion Oxygenator System
- K223630 — Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
- K223488 — ClosureFast Endovenous Radiofrequency Ablation Catheter
- K223508 — Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
- K221962 — LINQ II Insertable Cardiac Monitor
- K201057 — Bio-Medicus Life Support Catheter and Introducer
- K213631 — Chocolate PTA Balloon Catheter
- K212027 — TurboHawk Plus Directional Atherectomy System
- K212008 — Reveal LINQ Insertable Cardiac Monitor
- K201100 — Bio-Medicus Life Support Catheter and Introducer
- K203556 — Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
- K210484 — LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
- K211304 — LINQ II Insertable Cardiac Monitor
- K211057 — LigaPASS® Spinal System, CD Horizon Spinal System
- K192712 — Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter
- K200795 — LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit
- K201449 — SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring
- K201118 — Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level
- K201068 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface
- K201011 — Medtronic Model 5392 External Pulse Generator (EPG)
- K200074 — O-arm O2 Imaging System
- K200630 — Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
- K192636 — TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
- K192389 — TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
- K200456 — Becker External Drainage and Monitoring System
- K191526 — Cardioblate CryoFlex Surgical Ablation System
- K191444 — Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir
- K190574 — Patient Assistant Model PA97000
- K191077 — Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor
- K191029 — Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac
- K190825 — Medtronic Model 5392 External Pulse Generator (EPG)
- K183490 — Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
- K190557 — Bio-Medicus Insertion Kit
- K183353 — Telescope Guide Extension Catheter
- K183511 — Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241)
- K183493 — SelectSite C304-HIS Deflectable Catheter System
- K181918 — CardioInsight Cardiac Mapping System
- K182586 — DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port
- K181973 — Medtronic Model 5392 External Pulse Generator (EPG)
- K180122 — TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
- K180030 — TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
- K180873 — Medtronic Model 53401 External Pulse Generator (EPG)
- K180453 — Bio-Medicus Adult Cannulae and Introducer
- K180456 — Bio-Medicus Adult Cannulae Kit
- K173664 — Medtronic O-arm O2 Imaging System
- K172984 — Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
- K171979 — Tubing Pack
- K172626 — Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
- K171308 — Tubing Pack
- K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
- K163008 — CareLink SmartSync Device Manager - Pacing System Analyzer
- K163032 — Kyphon Xpede Bone Cement
- K162855 — Reveal LINQ
- K163460 — Reveal LINQ Insertable Cardiac Monitor
- K162774 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
- K162958 — MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge
- K162896 — Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
- K162892 — Achieve Advance Mapping Catheter
- K162054 — Medtronic Temporary External Pacemaker 53401
- K162550 — Medtronic Model 5392 External Pulse Generator (EPG)
- K162016 — Affinity NT Oxygenator with Cortiva BioActive Surface
- K160983 — Kyphon HV-R Bone Cement
- K160809 — Reveal LINQ
- K160091 — Temperature Probe, Affinity Temperature Probe
- K153139 — Achieve ST Mapping Catheter, Catheter Connecting Cable
- K160689 — Reveal LINQ
- K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
- K153160 — AVIVO Mobile Patient Management (MPM) System
- K153598 — Medtronic Bio-Medicus Adult Cannula Kit
- K152335 — Export Advance Aspiration Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.