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"
193–216 of 1,622
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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 Sep 20, 2019
Medtronic 6F Taiga Guiding Catheter
K192296 · DQY
Medtronic Vascular
Cardiovascular · 28d
Cleared Sep 12, 2019
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™...
K191148 · PML
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 135d
Cleared Aug 27, 2019
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
K191077 · KFM
Medtronic, Inc.
Cardiovascular · 126d
Cleared Aug 26, 2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
K191039 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 129d
Cleared Aug 08, 2019
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492...
K190716 · LDF
Medtronic
Cardiovascular · 142d
Cleared Jul 31, 2019
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial...
K190672 · HAW
Medtronic Navigation, Inc.
Neurology · 138d
Cleared Jul 30, 2019
Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
K190132 · DRF
Medtronic
Cardiovascular · 183d
Cleared Jul 30, 2019
Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable...
K183547 · DRF
Medtronic
Cardiovascular · 222d
Cleared Jul 26, 2019
Medtronic Total Hip Arthroplasty System
K183129 · LPH
Medtronic Advanced Energy
Orthopedic · 255d
Cleared Jul 03, 2019
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
K190959 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 82d
Cleared May 30, 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical...
K190623 · OCL
Medtronic
Cardiovascular · 80d
Cleared May 22, 2019
Stealth-Midas MR8 System
K183644 · OLO
Medtronic Powered Surgical Solutions
Orthopedic · 147d
Cleared May 17, 2019
Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator...
K191029 · DTZ
Medtronic, Inc.
Cardiovascular · 29d
Cleared May 12, 2019
MR8 Drill System, Midas Rex MR8 ClearView Tools
K183515 · HBC
Medtronic Powered Surgical Solutions
Neurology · 145d
Cleared May 06, 2019
Capstone Control™ Spinal System
K190165 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 95d
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 04, 2019
PYRAMESH™ Implant System
K183197 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 136d
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