FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

1,626 results for "Medtronic"
25–48 of 1,626
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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 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 Aug 29, 2025
SmartGuard technology
K251217 · QJI
Medtronic Minimed, Inc.
Chemistry · 130d
Cleared Aug 07, 2025
UNiD™ Spine Analyzer
K251629 · QIH
Medicrea International S.A.S....
Radiology · 71d
Cleared Jul 01, 2025
MiniMed 780G insulin pump
K251032 · QFG
Medtronic Minimed, Inc.
Chemistry · 89d
Cleared Jun 26, 2025
The Rialto™ SI Fusion System
K251395 · OUR
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 52d
Cleared Jun 20, 2025
MC2™ Two-Stage Venous Cannula
K251258 · DWF
Medtronic, Inc.
Cardiovascular · 58d
Cleared Jun 13, 2025
Medtronic Stedi Extra Support Guidewire
K250075 · DQX
Medtronic, Inc.
Cardiovascular · 154d