FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
23425–23448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2019
ELMED Laparoscopic Instruments and Accessories
K181173 · GCJ
Elmed Incorporated
General & Plastic Surgery · 324d
Cleared Mar 22, 2019
ON-Q* Pump with Bolus
K181360 · MEB
Halyard Health
General Hospital · 304d
Cleared Mar 22, 2019
Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing,...
K181624 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 275d
Cleared Mar 22, 2019
Polyethylene Catheter
K181722 · DQO
Cook Incorporated
Cardiovascular · 266d
Cleared Mar 22, 2019
Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors
K181738 · DQA
Surgical Instrument Service and...
Anesthesiology · 263d
Cleared Mar 22, 2019
HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)
K181959 · FRG
Owens & Minor Halyard, Inc.
General Hospital · 242d
Cleared Mar 22, 2019
CMOS Video-Rhino-Laryngoscope System
K182186 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 221d
Cleared Mar 22, 2019
OARtrac System
K182395 · NZT
Radialdyne, LLC
Radiology · 199d
Cleared Mar 22, 2019
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with...
K182554 · LZA
He Chuang Plastic & Rubber Co., Ltd.
General Hospital · 186d
Cleared Mar 22, 2019
Nexstim Navigated Brain Therapy (NBT) System 2
K182700 · OBP
Nexstim Plc
Neurology · 176d
Cleared Mar 22, 2019
ROSA ONE Spine application
K182848 · OLO
Medtech S.A
Orthopedic · 164d
Cleared Mar 22, 2019
Shiley Neonatal/Pediatric Tracheostomy Tube
K182861 · JOH
Covidien
Anesthesiology · 162d
Cleared Mar 22, 2019
Masimo Rad-67 Pulse CO-Oximeter and Accessories
K182887 · DQA
Masimo Corporation
Anesthesiology · 158d
Cleared Mar 22, 2019
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
K182948 · KGO
Ansell Healthcare Products, LLC
General Hospital · 150d
Cleared Mar 22, 2019
Nalu Neurostimulation System
K183047 · GZB
Boston Scientific Neuromodulation
Neurology · 140d
Cleared Mar 22, 2019
uWS-MR
K183164 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 127d
Cleared Mar 22, 2019
Telescope Guide Extension Catheter
K183353 · DQY
Medtronic, Inc.
Cardiovascular · 109d
Cleared Mar 22, 2019
EnVisio Navigation Sytem
K183400 · NEU
Elucent Medical, Inc.
General & Plastic Surgery · 105d
Cleared Mar 22, 2019
Aristotle 18 Guidewire, 200cm, Soft Profile
K183608 · MOF
Scientia Vascular, LLC
Neurology · 86d
Cleared Mar 22, 2019
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid...
K190104 · MED
Steris Corporations
General Hospital · 59d
Cleared Mar 22, 2019
MTS Gentamicin 0.016 - 256 µg/mL
K190252 · JWY
Liofilchem S. R. L.
Microbiology · 43d
Cleared Mar 22, 2019
OsteoCentric Bone Plate and Screw System
K190430 · HWC
Osteocentric Trauma
Orthopedic · 28d
Cleared Mar 21, 2019
A&D Medical Blood Pressure Monitors
K173191 · DXN
A&D Company, Ltd.
Cardiovascular · 535d
Cleared Mar 21, 2019
RENASYS Touch
K181822 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 255d