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"
97–120 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 19, 2023
StealthStation Cranial Software, v3.1.5 (9735585)
K231976 · HAW
Medtronic Navigation, Inc.
Neurology · 108d
Cleared Aug 30, 2023
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
K231580 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 91d
Cleared Aug 22, 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
K232190 · DQY
Medtronic Vascular
Cardiovascular · 29d
Cleared Aug 16, 2023
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw)
K232141 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jul 18, 2023
Robotic Graft Delivery Instruments
K230716 · OLO
Medtronic Sofamor Danek, Inc.
Orthopedic · 125d
Cleared Jun 30, 2023
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K230991 · NEZ
Given Imaging Ltd. (Medtronic)
Gastroenterology & Urology · 85d
Cleared Jun 30, 2023
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide...
K230156 · DQY
Medtronic Vascular
Cardiovascular · 162d
Cleared Jun 15, 2023
Zevo Anterior Cervical Plate System
K231090 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 59d
Cleared May 26, 2023
CD Horizon™ Spinal System
K231184 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
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 Jan 23, 2023
CD Horizon Spinal System
K223494 · NKB
Medtronic
Orthopedic · 63d
Cleared Jan 11, 2023
INFINITY OCT System
K223764 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Dec 22, 2022
Cardioblate Gemini-s 49260 Surgical Ablation Device
K223508 · OCL
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 16, 2022
Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
K223153 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Nov 08, 2022
SelectSite C304 Deflectable Catheter System, C315 Delivery System
K223178 · DQY
Medtronic
Cardiovascular · 28d
Cleared CT Nov 07, 2022
Attain Command + SureValve Delivery System, Attain Select II + SureValve...
K222873 · DQY
Medtronic
Cardiovascular · 46d
Cleared Oct 04, 2022
CD HORIZON™ ASTUTE™ SPINAL SYSTEM
K221646 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Sep 29, 2022
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX...
K222383 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 55d
Cleared Aug 25, 2022
LINQ II Insertable Cardiac Monitor
K221962 · MXD
Medtronic, Inc.
Cardiovascular · 51d