FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,622 results for "medtronic"
145–168 of 1,622
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 27, 2021
LigaPASS® Spinal System, CD Horizon™ Spinal System
K211057 · OWI
Medtronic, Inc.
Orthopedic · 48d
Cleared May 26, 2021
Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System,...
K211258 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 24, 2021
Catalyft PL Expandable Interbody System
K210425 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 102d
Cleared Apr 30, 2021
CD Horizon™ Spinal System
K210637 · NKB
Medtronic
Orthopedic · 58d
Cleared Mar 18, 2021
Infinity™ OCT System, PASS OCT® Spinal System
K210449 · NKG
Medtronic
Orthopedic · 30d
Cleared Jan 15, 2021
CD HORIZON™ Spinal System
K203678 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jan 13, 2021
StealthStation Cranial Software v1.3.2
K203639 · HAW
Medtronic Navigation, Inc.
Neurology · 30d
Cleared Dec 08, 2020
CD Horizon Spinal System Instruments
K203291 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 08, 2020
Novapak Nasal Sinus Packing and Stent
K202623 · LYA
Medtronic Xomed
Ear, Nose, Throat · 89d
Cleared Nov 18, 2020
Pacific Plus PTA Catheter
K202800 · LIT
Medtronic Vascular,Inc(Formerly D.B.A...
Cardiovascular · 56d
Cleared Nov 13, 2020
FlexCath Advance Steerable Sheath and Dilator
K202620 · DRA
Medtronic Cryocath, LP
Cardiovascular · 64d
Cleared Nov 02, 2020
Midas Rex Attachments and Dissecting Tools
K202552 · OLO
Medtronic Powered Surgical Solutions...
Orthopedic · 60d
Cleared Oct 28, 2020
NIM Vital, Nerve Integrity Monitor
K200759 · GWF
Medtronic Xomed, Inc.
Neurology · 218d
Cleared Oct 19, 2020
CD Horizon Spinal System
K202771 · NKB
Medtronic
Orthopedic · 28d
Cleared Oct 08, 2020
Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22
K193542 · KDI
Bellco Srl
Gastroenterology & Urology · 293d
Cleared Sep 10, 2020
CD Horizon™ Spinal System
K201407 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 105d
Cleared Sep 08, 2020
CD Horizon Spinal System
K202328 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 22d
Cleared Aug 26, 2020
Adaptix Interbody System with Titan nanoLOCK Surface Technology
K201267 · MAX
Medtronic Sofamor Danek
Orthopedic · 106d
Cleared Aug 19, 2020
CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™...
K201362 · PML
Medtronic
Orthopedic · 89d
Cleared Aug 03, 2020
Attain Select II + SureValve delivery catheter system, Attain Command +...
K192712 · DQY
Medtronic, Inc.
Cardiovascular · 311d
Cleared Jul 03, 2020
LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command...
K200795 · MXD
Medtronic, Inc.
Cardiovascular · 99d
Cleared Jul 02, 2020
AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable...
K200674 · DSA
Atrility Medical, LLC
Cardiovascular · 108d
Cleared Jul 01, 2020
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band,...
K201449 · KRH
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 26, 2020
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
K200723 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 99d