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"
1–24 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 29, 2026
DLP™ Coronary Ostial Cannulae
K263596 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Oct 29, 2026
Symmetrix™ PX Spinal System
K262572 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 94d
Cleared Oct 23, 2026
DLP PVC Left Heart Vent
K261792
Medtronic
Cardiovascular · 147d
Cleared Sep 17, 2026
Protégé™ EverFlex™ Self-expanding Peripheral Stent System
K262913 · FGE
Medtronic, Inc.
Gastroenterology & Urology · 29d
Cleared Sep 04, 2026
ApexCut ™ Blade with Automated EM Tracking (187BL4012EM)
K262235 · PGW
Medtronic Xomed, Inc.
Ear, Nose, Throat · 65d
Cleared Aug 28, 2026
LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
K262735 · MXD
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 21, 2026
Affera Integrated Mapping System
K262005 · DQK
Medtronic, Inc.
Cardiovascular · 67d
Cleared Aug 14, 2026
NC Euphora Rapid Exchange Balloon Dilatation Catheter
K261428 · LOX
Medtronic, Ireland
Cardiovascular · 106d
Cleared Jul 31, 2026
VitalFlow Set with Balance™ Biosurface
K261335 · QJZ
Medtronic, Inc.
Cardiovascular · 99d
Cleared Jul 27, 2026
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter
K261759 · LOX
Medtronic, Ireland
Cardiovascular · 60d
Cleared Jul 17, 2026
Catalyft PL Expandable Interbody System
K253011 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 301d
Cleared Jul 14, 2026
Symmetrix™ L Spinal System
K261020 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 109d
Cleared Jul 09, 2026
SmartGuard Technology
K261962 · QJI
Medtronic Minimed
Chemistry · 28d
Cleared Jun 24, 2026
Concerto Versa™ Detachable Coil
K261866 · KRD
Medtronic, Inc.
Cardiovascular · 20d
Cleared Jun 05, 2026
OsteoCool™ RF Ablation System
K253656 · GEI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 197d
Cleared May 28, 2026
Trexon™ Monofilament Synthetic Absorbable Suture
K253530 · GAM
Medtronic
General & Plastic Surgery · 196d
Cleared May 15, 2026
UNiD™ Spine Analyzer (SW3002)
K261289 · QIH
Medicrea International S.A.S....
Radiology · 25d
Cleared Apr 23, 2026
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
K260195 · DWF
Medtronic, Inc.
Cardiovascular · 91d
Cleared Apr 23, 2026
Liberant™ RX Aspiration Catheter
K253589 · QEZ
Medtronic Interventional Vascular, Inc.
Cardiovascular · 157d
Cleared Apr 21, 2026
CD Horizon™ ModuLeX™ Fenestrated Screw Set
K260216 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared CT Apr 10, 2026
Tri-staple 2.0™ Reloads
K253657 · GDW
Covidien (Part of Medtronic)
General & Plastic Surgery · 141d
Cleared Mar 26, 2026
Stealth AXiS Cranial clinical application
K253379 · HAW
Medtronic Navigation, Inc.
Neurology · 177d
Cleared Mar 16, 2026
Stealth AXiS™ ENT clinical application
K253395 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 167d
Cleared Mar 13, 2026
Visualase Cooled Laser Applicator System (9735559)
K253391 · ONO
Medtronic Navigation, Inc.
Neurology · 164d