Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

1,631 results for "Medtronic"
25–48 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 12, 2026
MiniMed Flex pump
K253743 · QFG
Medtronic Minimed, Inc.
Chemistry · 108d
Cleared Feb 19, 2026
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · DWF
Medtronic, Inc.
Cardiovascular · 146d
Cleared Feb 12, 2026
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application
K253381 · OLO
Medtronic Navigation, Inc.
Orthopedic · 135d
Cleared Feb 10, 2026
NIM Essence™ EMG Endotracheal Tube (NIMEID060)
K251672 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 256d
Cleared Feb 03, 2026
SmartGuard Technology
K253701 · QJI
Medtronic Minimed
Chemistry · 71d
Cleared Jan 21, 2026
Infinity™ OCT System
K254165 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jan 20, 2026
Clearview Intracoronary Shunts
K253998 · DWF
Medtronic, Inc.
Cardiovascular · 39d
Cleared Jan 17, 2026
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
K251970 · LOX
Medtronic, Ireland
Cardiovascular · 205d
Cleared Jan 16, 2026
Affinity Pixie™ Arterial Filter with Balance™ Biosurface
K251744 · DTM
Medtronic
Cardiovascular · 224d
Cleared Jan 15, 2026
MiniMed 780G Insulin Pump (MMT-1884)
K253470 · QFG
Medtronic Minimed, Inc.
Chemistry · 97d
Cleared Jan 15, 2026
Bio-Medicus Life Support Catheter and Introducer
K251831 · QHW
Medtronic, Inc.
Cardiovascular · 216d
Cleared CT Jan 14, 2026
SmartGuard technology
K253585 · QJI
Medtronic Minimed, Inc.
Chemistry · 58d
Cleared Jan 14, 2026
Concerto Versa™ Detachable Coil
K253511 · KRD
Medtronic, Inc.
Cardiovascular · 70d
Cleared Jan 08, 2026
MiniMed Go App
K253512 · NDC
Medtronic Minimed
Chemistry · 63d
Cleared Jan 07, 2026
CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)
K253941 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 19, 2025
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
K253577 · MAX
Medicrea International S.A.S....
Orthopedic · 32d
Cleared Dec 19, 2025
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48),...
K253409 · DQY
Medtronic, Inc.
Cardiovascular · 80d
Cleared Oct 29, 2025
Telescope Guide Extension Catheter
K252390 · DQY
Medtronic, Ireland
Cardiovascular · 90d
Cleared Oct 24, 2025
CD Horizon™ Spinal System
K253335 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 24d
Cleared Oct 24, 2025
Infinity™ OCT System
K253129 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Oct 24, 2025
Parietene™ Flat Sheet Mesh
K253125 · FTL
Medtronic - Sofradim Production
General & Plastic Surgery · 29d
Cleared Oct 17, 2025
StealthStation S8 Spine Software
K251282 · OLO
Medtronic Navigation, Inc.
Orthopedic · 176d
Cleared Sep 04, 2025
Endoskeleton™ Interbody Systems
K251444 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 118d
Cleared CT Aug 29, 2025
SmartGuard technology
K251217 · QJI
Medtronic Minimed, Inc.
Chemistry · 130d