FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

1,622 results for "Medtronic"
73–96 of 1,622
Search insights Median review: 79d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
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 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
Cleared Oct 19, 2023
StealthStation Cranial Software, v3.1.5 (9735585)
K231976 · HAW
Medtronic Navigation, Inc.
Neurology · 108d
Cleared Aug 30, 2023
NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
K231580 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 91d
Cleared Aug 22, 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
K232190 · DQY
Medtronic Vascular
Cardiovascular · 29d
Cleared Aug 16, 2023
CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw)
K232141 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jul 18, 2023
Robotic Graft Delivery Instruments
K230716 · OLO
Medtronic Sofamor Danek, Inc.
Orthopedic · 125d
Cleared Jun 30, 2023
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
K230991 · NEZ
Given Imaging Ltd. (Medtronic)
Gastroenterology & Urology · 85d
Cleared Jun 30, 2023
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide...
K230156 · DQY
Medtronic Vascular
Cardiovascular · 162d
Cleared Jun 15, 2023
Zevo Anterior Cervical Plate System
K231090 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 59d