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."
25–48 of 221
Search insights Median review: 70d Cleared: 100% Top manufacturer: Medtronic, Inc. Lead specialty: Cardiovascular
Cleared Mar 28, 2024
LINQ II™ Insertable Cardiac Monitor (ICM)
K240693 · MXD
Medtronic, Inc.
Cardiovascular · 15d
Cleared Mar 28, 2024
Emprint Ablation System with Thermosphere Technology (Overall System Name)
K233838 · NEY
Medtronic, Inc.
General & Plastic Surgery · 115d
Cleared CT Mar 08, 2024
Affera Mapping System (AFR-00003)
K233943 · DQK
Medtronic, Inc.
Cardiovascular · 85d
Cleared Dec 07, 2023
DLP Silicone Coronary Artery Ostial Cannulae
K231206 · DWF
Medtronic, Inc.
Cardiovascular · 224d
Cleared Dec 06, 2023
LINQ II Insertable Cardiac Monitor
K233562 · MXD
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 02, 2023
Cosine-10TM Diagnostic Catheter
K233397 · DRF
Medtronic, Inc.
Cardiovascular · 60d
Cleared Oct 31, 2023
LINQ II™ Insertable Cardiac Monitor (LNQ22)
K233320 · MXD
Medtronic, Inc.
Cardiovascular · 32d
Cleared Oct 31, 2023
FlexCath Contour™ Steerable Sheath
K232321 · DRA
Medtronic, Inc.
Cardiovascular · 89d
Cleared May 04, 2023
DLP™ Silicone Coronary Artery Ostial Cannulae
K230960 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 26, 2023
LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
K230553 · MXD
Medtronic, Inc.
Cardiovascular · 57d
Cleared Apr 19, 2023
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO)...
K223168 · QWF
Medtronic, Inc.
Cardiovascular · 190d
Cleared Apr 06, 2023
Affinity Fusion™ Oxygenator System
K230640 · DTZ
Medtronic, Inc.
Cardiovascular · 29d
Cleared Apr 05, 2023
Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor,...
K223630 · MXD
Medtronic, Inc.
Cardiovascular · 121d
Cleared Mar 23, 2023
ClosureFast™ Endovenous Radiofrequency Ablation Catheter
K223488 · GEI
Medtronic, Inc.
General & Plastic Surgery · 122d
Cleared Dec 22, 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
K223508 · OCL
Medtronic, Inc.
Cardiovascular · 30d
Cleared Aug 25, 2022
LINQ II Insertable Cardiac Monitor
K221962 · MXD
Medtronic, Inc.
Cardiovascular · 51d
Cleared Jan 14, 2022
Bio-Medicus Life Support Catheter and Introducer
K201057 · QHW
Medtronic, Inc.
Cardiovascular · 633d
Cleared Dec 15, 2021
Chocolate PTA Balloon Catheter
K213631 · LIT
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 24, 2021
TurboHawk Plus Directional Atherectomy System
K212027 · MCW
Medtronic, Inc.
Cardiovascular · 56d
Cleared Jul 22, 2021
Reveal LINQ Insertable Cardiac Monitor
K212008 · MXD
Medtronic, Inc.
Cardiovascular · 24d
Cleared Jul 15, 2021
Bio-Medicus Life Support Catheter and Introducer
K201100 · DWF
Medtronic, Inc.
Cardiovascular · 447d
Cleared Jul 12, 2021
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
K203556 · DSA
Medtronic, Inc.
Cardiovascular · 217d
Cleared Jun 11, 2021
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
K210484 · MXD
Medtronic, Inc.
Cardiovascular · 112d
Cleared May 28, 2021
LINQ II Insertable Cardiac Monitor
K211304 · MXD
Medtronic, Inc.
Cardiovascular · 29d