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"
49–72 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 07, 2025
UNiD™ Spine Analyzer
K251629 · QIH
Medicrea International S.A.S....
Radiology · 71d
Cleared Jul 01, 2025
MiniMed 780G insulin pump
K251032 · QFG
Medtronic Minimed, Inc.
Chemistry · 89d
Cleared Jun 26, 2025
The Rialto™ SI Fusion System
K251395 · OUR
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 52d
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 Jun 12, 2025
Grafton™ DBM
K251193 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 56d
Cleared Jun 11, 2025
Liberant Thrombectomy System
K250787 · QEW
Medtronic, Ireland
Cardiovascular · 89d
Cleared Jun 05, 2025
Stealth™ Spine Clamps
K242464 · OLO
Medtronic Navigation, Inc.
Orthopedic · 290d
Cleared May 29, 2025
Visualase V2 MRI-guided Laser Ablation System (9736422)
K250307 · ONO
Medtronic Navigation
Neurology · 115d
Cleared May 20, 2025
VitalFlow Console
K250199 · QNR
Medtronic, Inc.
Cardiovascular · 117d
Cleared Apr 22, 2025
Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
K250669 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 48d
Cleared Mar 27, 2025
SelectSite C304 Deflectable Catheter System (C304)
K250558 · DQY
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 10, 2025
Duet External Drainage and Monitoring System (EDMS)
K243676 · JXG
Medtronic Neurosurgery
Neurology · 103d
Cleared Jan 17, 2025
Affera Integrated Mapping System
K243892 · DQK
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jan 17, 2025
Mastergraft Matrix EXT
K243706 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 49d
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 12, 2024
InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
K242775 · NDC
Medtronic Minimed
Chemistry · 60d
Cleared Nov 01, 2024
Affera Integrated Mapping System
K241828 · DQK
Medtronic, Inc.
Cardiovascular · 130d
Cleared Nov 01, 2024
Signia™ Circular Adapter (Standard Length) (SIGCIRSTND)
K240881 · GAG
Covidien (Part of Medtronic)
General & Plastic Surgery · 214d
Cleared Oct 28, 2024
Catalyft™ LS Expandable Interbody System
K241992 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 112d
Cleared Oct 24, 2024
Duet External Drainage and Monitoring System (EDMS)
K242034 · PCB
Medtronic Neurosurgery
Neurology · 105d
Cleared Oct 23, 2024
CD Horizon™ Spinal System
K243007 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Sep 12, 2024
VitalFlow Set with Balance Biosurface
K240880 · QJZ
Medtronic, Inc.
Cardiovascular · 164d