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
24385–24408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2018
DENTIOIII series (DENTIOIII, DENTIOIII-S)
K181297 · MUH
Hdx Will Corp.
Radiology · 189d
Cleared Nov 21, 2018
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES...
K181454 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 170d
Cleared Nov 21, 2018
Transpara
K181704 · QDQ
Screenpoint Medical B.V.
Radiology · 147d
Cleared Nov 21, 2018
MATRx Plus
K181996 · MNR
Zephyr Sleep Technologies
Anesthesiology · 118d
Cleared Nov 21, 2018
Wet Organics Personal Lubricant
K182027 · NUC
Trigg Laboratories Dba Wet International
Obstetrics & Gynecology · 114d
Cleared Nov 21, 2018
Versana Premier
K182277 · IYN
GE Medical Systems Ultrasound and...
Radiology · 91d
Cleared Nov 21, 2018
SP-LINK™ System
K182352 · PEK
Medical Designs, LLC
Orthopedic · 84d
Cleared Nov 21, 2018
PlayMakar Sport Muscle Stimulator, Model PRO-500
K182581 · NUH
Playmakar, Inc.
Neurology · 63d
Cleared Nov 21, 2018
PINPOINT Endoscopic Fluorescence Imaging System
K182606 · GCJ
Novadaq Technologies Ulc. (Now A Part...
General & Plastic Surgery · 61d
Cleared Nov 21, 2018
ARK EDDP Assay
K182779 · DJR
ARK Diagnostics, Inc.
Toxicology · 51d
Cleared Nov 21, 2018
Roth Net Retriever Product Line
K182909 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 35d
Cleared Nov 21, 2018
Heli-FX EndoAnchor System
K182957 · OTD
Medtronic Vascular, Inc.
Cardiovascular · 28d
Cleared Nov 21, 2018
Isolette 8000 Plus
K182977 · FMZ
Draeger Medical Systems, Inc.
General Hospital · 26d
Cleared Nov 20, 2018
NuVasive Monolith Cervical Corpectomy System
K180550 · PLR
Nu Vasive, Incorporated
Orthopedic · 264d
Cleared Nov 20, 2018
GC Acrylic Primer
K180917 · KLE
GC America, Inc.
Dental · 225d
Cleared Nov 20, 2018
Vitrea CT Brain Perfusion
K181247 · LLZ
Vital Images, Inc.
Radiology · 194d
Cleared Nov 20, 2018
MR Compatible Aspiration Kit
K181731 · GWG
Mri Interventions, Inc.
Neurology · 144d
Cleared Nov 20, 2018
ARIX Sternal System
K181806 · HRS
Jeil Medical Corporation
Orthopedic · 137d
Cleared Nov 20, 2018
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low...
K181857 · LZA
Kossan International Sdn Bhd
General Hospital · 132d
Cleared Nov 20, 2018
Infrared Thermometer
K182133 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 106d
Cleared Nov 20, 2018
CodMan Certas Plus Programmable Valve
K182265 · JXG
Integra Lifesciences Corp.
Neurology · 91d
Cleared Nov 20, 2018
Orbit Subretinal Delivery System
K182274 · FMF
Orbit Biomedical, Inc.
Ophthalmic · 90d
Cleared Nov 20, 2018
TPH Spectra ST Flowable Composite Restorative
K182288 · EBF
Dentsply Sirona
Dental · 89d
Cleared Nov 20, 2018
6MP Color LCD Monitor (C61W+)
K182291 · PGY
Shenzhen Beacon Display Technology...
Radiology · 89d