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."
1–24 of 221
Search insights Median review: 70d Cleared: 100% Top manufacturer: Medtronic, Inc. Lead specialty: Cardiovascular
Cleared Oct 29, 2026
DLP™ Coronary Ostial Cannulae
K263596 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Sep 17, 2026
Protégé™ EverFlex™ Self-expanding Peripheral Stent System
K262913 · FGE
Medtronic, Inc.
Gastroenterology & Urology · 29d
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 Jul 31, 2026
VitalFlow Set with Balance™ Biosurface
K261335 · QJZ
Medtronic, Inc.
Cardiovascular · 99d
Cleared Jun 24, 2026
Concerto Versa™ Detachable Coil
K261866 · KRD
Medtronic, Inc.
Cardiovascular · 20d
Cleared Apr 23, 2026
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
K260195 · DWF
Medtronic, Inc.
Cardiovascular · 91d
Cleared Feb 19, 2026
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · DWF
Medtronic, Inc.
Cardiovascular · 146d
Cleared Jan 20, 2026
Clearview Intracoronary Shunts
K253998 · DWF
Medtronic, Inc.
Cardiovascular · 39d
Cleared Jan 15, 2026
Bio-Medicus Life Support Catheter and Introducer
K251831 · QHW
Medtronic, Inc.
Cardiovascular · 216d
Cleared Jan 14, 2026
Concerto Versa™ Detachable Coil
K253511 · KRD
Medtronic, Inc.
Cardiovascular · 70d
Cleared Dec 19, 2025
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48),...
K253409 · DQY
Medtronic, Inc.
Cardiovascular · 80d
Cleared Jun 20, 2025
MC2™ Two-Stage Venous Cannula
K251258 · DWF
Medtronic, Inc.
Cardiovascular · 58d
Cleared Jun 13, 2025
Medtronic Stedi Extra Support Guidewire
K250075 · DQX
Medtronic, Inc.
Cardiovascular · 154d
Cleared May 20, 2025
VitalFlow Console
K250199 · QNR
Medtronic, Inc.
Cardiovascular · 117d
Cleared Mar 27, 2025
SelectSite C304 Deflectable Catheter System (C304)
K250558 · DQY
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jan 17, 2025
Affera Integrated Mapping System
K243892 · DQK
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jan 17, 2025
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline...
K242705 · LDF
Medtronic, Inc.
Cardiovascular · 130d
Cleared Dec 05, 2024
Magnetic Localization Patch Kit (AFR-00021)
K243435 · DQK
Medtronic, Inc.
Cardiovascular · 30d
Cleared Nov 01, 2024
Affera Integrated Mapping System
K241828 · DQK
Medtronic, Inc.
Cardiovascular · 130d
Cleared Sep 12, 2024
VitalFlow Set with Balance Biosurface
K240880 · QJZ
Medtronic, Inc.
Cardiovascular · 164d
Cleared Jun 12, 2024
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541)
K241352 · DTZ
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 03, 2024
Amplatz Goose Neck Snare Kit
K241259 · MMX
Medtronic, Inc.
Cardiovascular · 28d
Cleared Apr 19, 2024
Bio-Medicus Life Support Catheter and Introducer
K240534 · QHW
Medtronic, Inc.
Cardiovascular · 53d