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
29785–29808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2017
FIRMap Catheter
K163709 · MTD
Abbott Electrophysiology
Cardiovascular · 60d
Cleared Feb 28, 2017
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
K170008 · KNW
Cook Incorporated
Gastroenterology & Urology · 56d
Cleared Feb 28, 2017
Jac-Cell Medic testers
K170105 · GEI
Jac-Cell Medic
General & Plastic Surgery · 47d
Cleared Feb 28, 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283 · FOZ
Becton, Dickinson and Company
General Hospital · 29d
Cleared CT Feb 27, 2017
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA...
K161853 · JXG
Aesculap, Inc.
Neurology · 236d
Cleared Feb 27, 2017
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
K162903 · KWT
Exactech, Inc.
Orthopedic · 133d
Cleared Feb 27, 2017
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP...
K162982 · LZA
Medline Industries, Inc.
General Hospital · 124d
Cleared Feb 27, 2017
Kyphon Xpede Bone Cement
K163032 · NDN
Medtronic, Inc.
Orthopedic · 119d
Cleared Feb 27, 2017
ComfortGuard Surgical Gown, i600, Film Reinforced
K163191 · FYA
Gri Medical & Electrical Technology...
General Hospital · 105d
Cleared Feb 27, 2017
BD PosiFlush Heparin Lock Flush Syringe
K163591 · NZW
Becton, Dickinson and Company
General Hospital · 69d
Cleared Feb 27, 2017
Flextra Steerable Introducer
K170373 · DYB
Rhythm Xience, Inc. (Rxi)
Cardiovascular · 20d
Cleared Feb 24, 2017
DT-100
K160358 · FLL
Mediana Co., Ltd.
General Hospital · 381d
Cleared Feb 24, 2017
HF 718BD X-Ray System
K160857 · KPR
Arquilla, Inc. Dba X-Cel X-Ray...
Radiology · 332d
Cleared Feb 24, 2017
Sonoma Fifth Metatarsal Repair System
K161371 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 283d
Cleared Feb 24, 2017
The Red Head Collection Device, The Jordy Connection System
K161372 · MUU
Miami Fat Supply
General & Plastic Surgery · 283d
Cleared Feb 24, 2017
ZIIP Device
K161484 · NFO
Ziip,Llc
Neurology · 269d
Cleared Feb 24, 2017
Watch-PAT200U
K161579 · MNR
Itamar Medical , Ltd.
Anesthesiology · 262d
Cleared Feb 24, 2017
MagnetOs
K161859 · MQV
Xpand Biotechnology BV
Orthopedic · 233d
Cleared Feb 24, 2017
TG-970P CO2 Sensor Kit
K161860 · CCK
Nihon Kohden Corporation
Anesthesiology · 233d
Cleared Feb 24, 2017
IllumiFlow Laser Cap
K162071 · OAP
Eglobal, LLC
General & Plastic Surgery · 212d
Cleared Feb 24, 2017
Dental Implants OKTAGON Tissue Level and Bone Level
K162073 · DZE
Hager& Meisinger GmbH
Dental · 212d
Cleared Feb 24, 2017
The ViewRay (MRIdian) Linac System
K162393 · IYE
Viewray, Incorporated
Radiology · 182d
Cleared Feb 24, 2017
ARTIA Reconstructive Tissue Matrix Perforated
K162752 · FTM
Lifecell Corporation
General & Plastic Surgery · 147d
Cleared Feb 24, 2017
EkoSonic Endovascular System with Control Unit 4.0
K162771 · QEY
Btg International, Inc.
Cardiovascular · 144d