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"
241–264 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 01, 2018
StrataMR guider tool
K181622 · JXG
Medtronic Neurosurgery
Neurology · 103d
Cleared Sep 19, 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K181328 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 124d
Cleared Aug 29, 2018
CD HORIZON™ Spinal System
K182119 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 23d
Cleared Aug 24, 2018
Solitaire 2 and Solitaire Platinum Revascularization Device
K181060 · POL
Medtronic Neurovascular
Neurology · 123d
Cleared Aug 22, 2018
autoLog IQ Autotransfusion System
K181954 · CAC
Medtronic Perfusion Systems
Cardiovascular · 30d
Cleared Aug 21, 2018
Medtronic Model 5392 External Pulse Generator (EPG)
K181973 · DTE
Medtronic, Inc.
Cardiovascular · 28d
Cleared Aug 02, 2018
PlasmaBlade X 3.0S, PlasmaBlade X 4.0
K181257 · GEI
Medtronic Advanced Energy
General & Plastic Surgery · 83d
Cleared Jul 11, 2018
Ziehm RFD 3D Tracker
K180816 · OLO
Medtronic Navigation
Orthopedic · 104d
Cleared Jun 07, 2018
TYRX Neuro Absorbable Antibacterial Envelope (medium)
K180122 · FTL
Medtronic, Inc.
General & Plastic Surgery · 142d
Cleared May 29, 2018
Tri-Ad 2.0 Adams Tricuspid Band
K181132 · KRH
Medtronic
Cardiovascular · 29d
Cleared May 18, 2018
KYPHON HV-R Bone Cement
K180700 · NDN
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared May 17, 2018
Navigated INFINITY Instruments
K181111 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared May 03, 2018
Medtronic Confida Brecker Guidewire
K181001 · DQX
Medtronic Core Valve, LLC
Cardiovascular · 17d
Cleared Apr 24, 2018
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable...
K180030 · FTL
Medtronic, Inc.
General & Plastic Surgery · 111d
Cleared Apr 20, 2018
Sharpsite AC Rigid Endsocope
K173855 · EOB
Medtronic Xomed, Inc.
Ear, Nose, Throat · 121d
Cleared Apr 19, 2018
Medtronic Model 53401 External Pulse Generator (EPG)
K180873 · DTE
Medtronic, Inc.
Cardiovascular · 16d
Cleared Apr 18, 2018
VERTEX™ Reconstruction System
K180851 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Apr 12, 2018
Admiral Xtreme
K173515 · LIT
Medtronic Vascular
Cardiovascular · 149d
Cleared Mar 22, 2018
Bio-Medicus Adult Cannulae Kit
K180456 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 22, 2018
Bio-Medicus Adult Cannulae and Introducer
K180453 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Mar 08, 2018
CD HORIZON™ Spinal System
K173249 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 149d
Cleared Jan 18, 2018
Navigated INFINITY™ Instruments
K173338 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Dec 29, 2017
Medtronic O-arm O2 Imaging System
K173664 · OWB
Medtronic, Inc.
Radiology · 30d
Cleared Dec 20, 2017
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125 · MQP
Medtronic Sofamor Danek
Orthopedic · 82d