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"
121–144 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 10, 2022
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
K221087 · HAW
Medtronic Navigation, Inc.
Neurology · 58d
Cleared May 25, 2022
CD Horizon™ Spinal System
K221244 · NKB
Medtronic
Orthopedic · 23d
Cleared May 25, 2022
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated...
K221180 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Apr 13, 2022
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
K220773 · MAV
Medtronic Vascular
Cardiovascular · 28d
Cleared Apr 12, 2022
Anteralign Spinal System with Titan nanoLOCK Surface Technology
K214010 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 111d
Cleared Apr 06, 2022
Extended Reservoir
K210714 · LZG
Medtronic Minimed, Inc.
Chemistry · 392d
Cleared Mar 21, 2022
NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball...
K213246 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 172d
Cleared Feb 09, 2022
Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™...
K214011 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Jan 14, 2022
Bio-Medicus Life Support Catheter and Introducer
K201057 · QHW
Medtronic, Inc.
Cardiovascular · 633d
Cleared Jan 07, 2022
Visualase MRI-Guided Laser Ablation System (SW 3.4)
K211269 · ONO
Medtronic Navigation, Inc.
Neurology · 255d
Cleared Dec 22, 2021
StealthStation S8 Cranial v2.0
K212397 · HAW
Medtronic Navigation
Neurology · 142d
Cleared Dec 15, 2021
Chocolate PTA Balloon Catheter
K213631 · LIT
Medtronic, Inc.
Cardiovascular · 28d
Cleared Dec 13, 2021
Centerpiece Plate Fixation System
K212428 · NQW
Medtronic Sofamor Danek
Orthopedic · 131d
Cleared Dec 08, 2021
Anteralign Spinal System with Titan nanoLOCK Surface Technology
K212524 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 119d
Cleared Nov 23, 2021
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm,...
K213454 · HBE
Medtronic Powered Surgical Solutions
Neurology · 28d
Cleared Nov 19, 2021
Catalyft LS Expandable Interbody System
K212653 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Sep 16, 2021
StrataMR II Valves and Shunts
K212641 · JXG
Medtronic Neurosurgery
Neurology · 27d
Cleared Sep 16, 2021
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
K203111 · DTZ
Medtronic
Cardiovascular · 336d
Cleared Aug 27, 2021
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K211684 · NEZ
Given Imaging Ltd. (Medtronic)
Gastroenterology & Urology · 87d
Cleared Aug 24, 2021
TurboHawk Plus Directional Atherectomy System
K212027 · MCW
Medtronic, Inc.
Cardiovascular · 56d
Not Cleared Aug 23, 2021
SureTune4 Software
DEN210003 · QQC
Medtronic Neuromodulation
Neurology · 201d
Cleared Aug 16, 2021
NuVent Eustachian Tube Dilation Balloon
K210841 · PNZ
Medtronic Xomed, Inc.
Ear, Nose, Throat · 147d
Cleared Jul 22, 2021
Reveal LINQ Insertable Cardiac Monitor
K212008 · MXD
Medtronic, Inc.
Cardiovascular · 24d
Cleared Jul 21, 2021
CD Horizon Spinal System
K211958 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d