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"
73–96 of 1,631
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Sep 06, 2024
IB3D™ PL Spinal System
K241164 · MAX
Medicrea International S.A.S....
Orthopedic · 133d
Cleared Aug 07, 2024
Sphere-9Dx Diagnostic Catheter (AFR-00009)
K233433 · MTD
Medtronic
Cardiovascular · 300d
Cleared Jul 10, 2024
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance...
K240666 · DTZ
Medtronic Perfusion Systems
Cardiovascular · 124d
Cleared Jul 02, 2024
Extended Reservoir
K241622 · LZG
Medtronic Minimed
Chemistry · 27d
Cleared Jun 21, 2024
O-arm O2 Imaging System
K240465 · OWB
Medtronic Navigation, Inc.
Radiology · 126d
Cleared Jun 12, 2024
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541)
K241352 · DTZ
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 07, 2024
Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
K240972 · NLH
Surgical Instrument Service and...
Cardiovascular · 59d
Cleared Jun 03, 2024
Amplatz Goose Neck Snare Kit
K241259 · MMX
Medtronic, Inc.
Cardiovascular · 28d
Cleared May 15, 2024
MVR™ Venous Reservoir Bag 800 mL
K241053 · DTN
Medtronic Cardiac Surgery
Cardiovascular · 28d
Cleared May 10, 2024
PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader...
K240276 · NEZ
Given Imaging Ltd. (D.B.A. Medtronic)
Gastroenterology & Urology · 100d
Cleared Apr 19, 2024
Bio-Medicus Life Support Catheter and Introducer
K240534 · QHW
Medtronic, Inc.
Cardiovascular · 53d
Cleared Mar 28, 2024
LINQ II™ Insertable Cardiac Monitor (ICM)
K240693 · MXD
Medtronic, Inc.
Cardiovascular · 15d
Cleared Mar 28, 2024
Emprint Ablation System with Thermosphere Technology (Overall System Name)
K233838 · NEY
Medtronic, Inc.
General & Plastic Surgery · 115d
Cleared Mar 27, 2024
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
K233951 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 103d
Cleared CT Mar 08, 2024
Affera Mapping System (AFR-00003)
K233943 · DQK
Medtronic, Inc.
Cardiovascular · 85d
Cleared Feb 28, 2024
OsteoCool™ 2.0 RF Ablation System
K233830 · GEI
Medtronic Sofamor Danek USA, Inc.
General & Plastic Surgery · 89d
Cleared Feb 23, 2024
MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface,...
K240190 · DTR
Medtronic
Cardiovascular · 30d
Cleared Dec 07, 2023
DLP Silicone Coronary Artery Ostial Cannulae
K231206 · DWF
Medtronic, Inc.
Cardiovascular · 224d
Cleared Dec 06, 2023
LINQ II Insertable Cardiac Monitor
K233562 · MXD
Medtronic, Inc.
Cardiovascular · 30d
Cleared Dec 02, 2023
Cosine-10TM Diagnostic Catheter
K233397 · DRF
Medtronic, Inc.
Cardiovascular · 60d
Cleared Oct 31, 2023
LINQ II™ Insertable Cardiac Monitor (LNQ22)
K233320 · MXD
Medtronic, Inc.
Cardiovascular · 32d
Cleared Oct 31, 2023
FlexCath Contour™ Steerable Sheath
K232321 · DRA
Medtronic, Inc.
Cardiovascular · 89d
Cleared Oct 26, 2023
NIM Standard Reinforced EMG Endotracheal Tube
K230320 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 262d
Cleared Oct 24, 2023
Steerant™ Super Stiff Guidewire
K232570 · DQX
Medtronic Vascular
Cardiovascular · 61d