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"
169–192 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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
Cleared Jun 18, 2020
NavLock Trackers
K201327 · OLO
Medtronic Navigation
Orthopedic · 30d
Cleared Jun 03, 2020
StealthStation Cranial Software v1.3.0
K201175 · HAW
Medtronic Navigation, Inc.
Neurology · 33d
Cleared Jun 03, 2020
Cardioblate Gemini-s Surgical Ablation Device
K200514 · OCL
Medtronic
Cardiovascular · 93d
Cleared May 29, 2020
Stealthstation S8 Spine Software v1.3.0
K201189 · OLO
Medtronic Navigation, Inc.
Orthopedic · 28d
Cleared May 26, 2020
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level,...
K201118 · GWM
Medtronic, Inc.
Neurology · 29d
Cleared May 21, 2020
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
K201068 · KFM
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 15, 2020
Medtronic Commander Flex
K191745 · DXN
Medtronic Care Management Services
Cardiovascular · 319d
Cleared May 13, 2020
Medtronic Model 5392 External Pulse Generator (EPG)
K201011 · DTE
Medtronic, Inc.
Cardiovascular · 26d
Not Cleared Apr 29, 2020
CARPEDIEM System
DEN180055 · QIR
Bellco Srl (Now Part of Medtronic, Inc)
Gastroenterology & Urology · 568d
Cleared Apr 24, 2020
O-arm O2 Imaging System
K200074 · OWB
Medtronic, Inc.
Radiology · 101d
Cleared Apr 09, 2020
Medtronic External Drainage and Monitoring System, Medtronic External...
K200630 · GWM
Medtronic, Inc.
Neurology · 30d
Cleared Apr 08, 2020
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable...
K192636 · FTL
Medtronic, Inc.
General & Plastic Surgery · 198d
Cleared Mar 27, 2020
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable...
K192389 · FTL
Medtronic, Inc.
General & Plastic Surgery · 206d
Cleared Mar 26, 2020
Becker External Drainage and Monitoring System
K200456 · GWM
Medtronic, Inc.
Neurology · 30d
Cleared Mar 24, 2020
PlasmaBlade X 3.0S LIGHT
K193579 · GEI
Medtronic Navigation
General & Plastic Surgery · 92d
Cleared Mar 23, 2020
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal...
K191788 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 264d