Medical Device Manufacturer · US , Minneapolis , MN

Medtronic

32 submissions · 32 cleared · Since 2007
32
Total
32
Cleared
0
Denied

Medtronic — FDA 510(k) Submissions

Medtronic has submitted 32 FDA 510(k) premarket notifications since 2007, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue, Electrode, Pacemaker, Temporary, Bone Cement, Posterior Screw Augmentation, Confocal Optical Imaging . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
Affinity Pixie? Arterial Filter with Balance? Biosurface; Affinity? Pediatric Arterial Blood Filter
K251744 · DTM Filter, Blood,... · Cardiovascular
Jan 2026 224d
Sphere-9Dx Diagnostic Catheter (AFR-00009)
K233433 · MTD Catheter, Intracardiac... · Cardiovascular
Aug 2024 300d
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
K240190 · DTR Heat-exchanger,... · Cardiovascular
Feb 2024 30d
CD Horizon Spinal System
K223494 · NKB Thoracolumbosacral... · Orthopedic
Jan 2023 63d
SelectSite C304 Deflectable Catheter System, C315 Delivery System
K223178 · DQY Catheter, Percutaneous · Cardiovascular
Nov 2022 28d
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
K222873 · DQY Catheter, Percutaneous · Cardiovascular
Nov 2022 46d
CD Horizon? Spinal System
K221244 · NKB Thoracolumbosacral... · Orthopedic
May 2022 23d
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
K203111 · DTZ Oxygenator,... · Cardiovascular
Sep 2021 336d
CD Horizon Spinal System
K211596 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2021 30d
CD Horizon? Spinal System
K210637 · NKB Thoracolumbosacral... · Orthopedic
Apr 2021 58d
Infinity? OCT System, PASS OCT? Spinal System
K210449 · NKG Posterior Cervical Screw... · Orthopedic
Mar 2021 30d
CD Horizon Spinal System
K202771 · NKB Thoracolumbosacral... · Orthopedic
Oct 2020 28d
CD Horizon? Fenestrated Screw Set, CD Horizon? Spinal System, Kyphon? HV-R? Bone Cement
K201362 · PML Bone Cement, Posterior... · Orthopedic
Aug 2020 89d
Cardioblate Gemini-s Surgical Ablation Device
K200514 · OCL Surgical Device, For... · Cardiovascular
Jun 2020 93d
VS3-IR
K191851 · OWN Confocal Optical Imaging · General & Plastic Surgery
Nov 2019 138d
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
K190716 · LDF Electrode, Pacemaker,... · Cardiovascular
Aug 2019 142d
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
K183547 · DRF Catheter, Electrode... · Cardiovascular
Jul 2019 222d
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
K190132 · DRF Catheter, Electrode... · Cardiovascular
Jul 2019 183d
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
K190623 · OCL Surgical Device, For... · Cardiovascular
May 2019 80d
VS3-IR
K183453 · OWN Confocal Optical Imaging · General & Plastic Surgery
Mar 2019 81d
Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
K182610 · OCL Surgical Device, For... · Cardiovascular
Dec 2018 89d
Tri-Ad 2.0 Adams Tricuspid Band
K181132 · KRH Ring, Annuloplasty · Cardiovascular
May 2018 29d
KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set
K171938 · PML Bone Cement, Posterior... · Orthopedic
Oct 2017 117d
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead
K171253 · LDF Electrode, Pacemaker,... · Cardiovascular
May 2017 27d
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
K161249 · LDF Electrode, Pacemaker,... · Cardiovascular
Aug 2016 108d
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