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

221 results for "medtronic, inc."
49–72 of 221
Search insights Median review: 70d Cleared: 100% Top manufacturer: Medtronic, Inc. Lead specialty: Cardiovascular
Cleared May 27, 2021
LigaPASS® Spinal System, CD Horizon™ Spinal System
K211057 · OWI
Medtronic, Inc.
Orthopedic · 48d
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 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 01, 2020
SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band,...
K201449 · KRH
Medtronic, Inc.
Cardiovascular · 30d
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 13, 2020
Medtronic Model 5392 External Pulse Generator (EPG)
K201011 · DTE
Medtronic, Inc.
Cardiovascular · 26d
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 Oct 01, 2019
Cardioblate CryoFlex Surgical Ablation System
K191526 · OCL
Medtronic, Inc.
Cardiovascular · 113d
Cleared Sep 27, 2019
Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with...
K191444 · DTZ
Medtronic, Inc.
Cardiovascular · 119d
Cleared Sep 24, 2019
Patient Assistant Model PA97000
K190574 · DSI
Medtronic, Inc.
Cardiovascular · 202d
Cleared Aug 27, 2019
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
K191077 · KFM
Medtronic, Inc.
Cardiovascular · 126d
Cleared May 17, 2019
Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator...
K191029 · DTZ
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 30, 2019
Medtronic Model 5392 External Pulse Generator (EPG)
K190825 · DTE
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 23, 2019
EverCrossTM 0.035 OTW PTA Dilatation Catheter
K190753 · LIT
Medtronic, Inc. (Formerly D.B.A. Ev3,...
Cardiovascular · 29d
Cleared Apr 12, 2019
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface,...
K183490 · DTZ
Medtronic, Inc.
Cardiovascular · 116d
Cleared Apr 03, 2019
Bio-Medicus Insertion Kit
K190557 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Mar 22, 2019
Telescope Guide Extension Catheter
K183353 · DQY
Medtronic, Inc.
Cardiovascular · 109d
Cleared Mar 18, 2019
Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity...
K183511 · DTZ
Medtronic, Inc.
Cardiovascular · 90d