Search FDA 510(k) Database

6,476 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
8761–8784 of 174,061
Cleared Jun 30, 2023
REMI Remote EEG Monitoring System
K230933 · OMC
Epitel, Inc.
Neurology · 88d
Cleared Jun 30, 2023
enspire 3000 Cleaning and Liquid Chemical Sterile Processing System
K230930 · FEB
STERIS Corporation
General Hospital · 88d
Cleared Jun 30, 2023
FebriDx Bacterial / Non-bacterial Point of Care Assay
K230917 · QXA
Lumos Diagnostics, Inc.
Microbiology · 88d
Cleared Jun 30, 2023
Compact Wearable Pump
K230469 · HGX
Lansinoh Laboratories
Obstetrics & Gynecology · 129d
Cleared Jun 30, 2023
SGM Femoral Nail System
K230456 · HSB
Changzhou Geasure Medical Apparatus...
Orthopedic · 129d
Cleared Jun 30, 2023
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide...
K230156 · DQY
Medtronic Vascular
Cardiovascular · 162d
Cleared Jun 30, 2023
Inogen Rove 6
K230052 · CAW
Inogen, Inc.
Anesthesiology · 175d
Cleared Jun 30, 2023
Unistik® ShieldLock, Unistik VacuFlip
K223854 · JKA
Owen Mumford, Ltd.
General Hospital · 189d
Cleared Jun 30, 2023
Tinearity G1 (6103)
K223694 · KLW
Duearity AB
Ear, Nose, Throat · 203d
Cleared Jun 30, 2023
Blood Pressure Monitor
K223374 · DXN
Guangdong Transtek Medical...
Cardiovascular · 238d
Cleared Jun 30, 2023
AblatePal Radiofrequency Ablation System
K223135 · GEI
Compal Electronics, Inc.
General & Plastic Surgery · 270d
Cleared Jun 30, 2023
AirTom
K222466 · QEB
Bilab
Anesthesiology · 318d
Cleared Jun 30, 2023
preCARDIA Occlusion System
K221294 · MJN
Abiomed, Inc.
Cardiovascular · 422d
Cleared Jun 30, 2023
Pixyl.Neuro
K213253 · LLZ
Pixyl SA
Radiology · 638d
Cleared Jun 30, 2023
Ulspira TS Nitric Oxide Therapy System
K212409 · MRN
Airgas Therapeutics
Anesthesiology · 696d
Cleared Jun 29, 2023
Phantom XL Insulated Dilators
K231691 · GXZ
TeDan Surgical Innovations, Inc.
Neurology · 20d
Cleared Jun 29, 2023
XENOVIEW 3.0T Chest Coil
K231647 · MOS
Polarean, Inc.
Radiology · 24d
Cleared Jun 29, 2023
OverStitch NXT Endoscopic Suturing System
K231553 · OCW
Apollo Endosurgery, Inc.
General & Plastic Surgery · 30d
Cleared Jun 29, 2023
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K231549 · OTN
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jun 29, 2023
Flume Catheter
K231101 · EZL
Flume Catheter Company, Ltd.
Gastroenterology & Urology · 72d
Cleared Jun 29, 2023
HotDog Warming Mattress + Return Electrode
K230866 · DWJ
Augustine Temperature Management, LLC
Cardiovascular · 92d
Cleared Jun 29, 2023
OsteoCentric ACL Fixation System
K230595 · HWC
OsteoCentric Technologies
Orthopedic · 118d
Cleared Jun 29, 2023
Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation...
K230374 · LOX
Dongguan TT Medical, Inc.
Cardiovascular · 136d
Cleared Jun 29, 2023
EarliPoint
K230337 · QPF
Earlitec Diagnostics, Inc.
Neurology · 142d