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."
73–96 of 221
Search insights Median review: 70d Cleared: 100% Top manufacturer: Medtronic, Inc. Lead specialty: Cardiovascular
Cleared Mar 15, 2019
SelectSite C304-HIS Deflectable Catheter System
K183493 · DQY
Medtronic, Inc.
Cardiovascular · 88d
Cleared Nov 08, 2018
CardioInsight Cardiac Mapping System
K181918 · DQK
Medtronic, Inc.
Cardiovascular · 113d
Cleared Oct 19, 2018
DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure...
K182586 · DWF
Medtronic, Inc.
Cardiovascular · 29d
Cleared Aug 21, 2018
Medtronic Model 5392 External Pulse Generator (EPG)
K181973 · DTE
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jun 07, 2018
TYRX Neuro Absorbable Antibacterial Envelope (medium)
K180122 · FTL
Medtronic, Inc.
General & Plastic Surgery · 142d
Cleared Apr 24, 2018
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable...
K180030 · FTL
Medtronic, Inc.
General & Plastic Surgery · 111d
Cleared Apr 19, 2018
Medtronic Model 53401 External Pulse Generator (EPG)
K180873 · DTE
Medtronic, Inc.
Cardiovascular · 16d
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 Dec 29, 2017
Medtronic O-arm O2 Imaging System
K173664 · OWB
Medtronic, Inc.
Radiology · 30d
Cleared Nov 20, 2017
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator...
K172984 · DTZ
Medtronic, Inc.
Cardiovascular · 54d
Cleared Oct 27, 2017
Tubing Pack
K171979 · DWF
Medtronic, Inc.
Cardiovascular · 119d
Cleared Oct 25, 2017
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion...
K172626 · DTZ
Medtronic, Inc.
Cardiovascular · 54d
Cleared Jun 02, 2017
Tubing Pack
K171308 · DWF
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 02, 2017
Responsive Orthopedics Total Hip Arthroplasty System
K163585 · LZO
Responsive Orthopedics, LLC
Orthopedic · 164d
Cleared Mar 17, 2017
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
K170583 · DTN
Medtronic, Inc.
Cardiovascular · 17d
Cleared Feb 28, 2017
CareLink SmartSync Device Manager - Pacing System Analyzer
K163008 · DTA
Medtronic, Inc.
Cardiovascular · 123d
Cleared Feb 27, 2017
Kyphon Xpede Bone Cement
K163032 · NDN
Medtronic, Inc.
Orthopedic · 119d
Cleared Feb 23, 2017
Reveal LINQ
K162855 · MXD
Medtronic, Inc.
Cardiovascular · 134d
Cleared Feb 14, 2017
Reveal LINQ Insertable Cardiac Monitor
K163460 · MXD
Medtronic, Inc.
Cardiovascular · 67d
Cleared Feb 10, 2017
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface,...
K162774 · DTR
Medtronic, Inc.
Cardiovascular · 130d
Cleared Feb 01, 2017
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface
K162958 · DTR
Medtronic, Inc.
Cardiovascular · 100d
Cleared Dec 06, 2016
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
K162896 · DTZ
Medtronic, Inc.
Cardiovascular · 50d
Cleared Nov 15, 2016
Achieve Advance Mapping Catheter
K162892 · DRF
Medtronic, Inc.
Cardiovascular · 29d