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
20233–20256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 2020
BSD3543W
K200787 · MQB
Bontech Co., Ltd.
Radiology · 28d
Cleared Apr 23, 2020
Surgical Face Mask
K200847 · FXX
Mexpo International, Inc.
General Hospital · 23d
Cleared Apr 22, 2020
Infrared Forehead Thermometer
K190984 · FLL
Xiamen Ants Bro Technology Co., Ltd.
General Hospital · 373d
Cleared CT Apr 22, 2020
Masimo Centroid System
K191882 · MWI
Masimo Corporation
Anesthesiology · 282d
Cleared Apr 22, 2020
FAICO CMF System
K191997 · JEY
Faico Medical, LLC
Dental · 271d
Cleared Apr 22, 2020
Psychemedics Microplate EIA for Cotinine in Hair
K192517 · MKU
Psychemedics Corporation
Toxicology · 222d
Cleared Apr 22, 2020
Dermapose Access
K200168 · QPB
Puregraft, LLC
General & Plastic Surgery · 90d
Cleared Apr 22, 2020
SYLFIRM X
K200185 · GEI
VIOL Co., Ltd.
General & Plastic Surgery · 89d
Cleared Apr 22, 2020
Acuson SC2000 Diagnostic Ultrasound System
K200585 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 47d
Cleared Apr 22, 2020
DB-Orthopedics
K200752 · MQV
Dimensional Bioceramics, LLC
Orthopedic · 30d
Cleared CT Apr 22, 2020
Indigo Aspiration System Lightning Aspiration Tubing
K200771 · QEW
Penumbra, Inc.
Cardiovascular · 28d
Cleared Apr 21, 2020
HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way...
K192034 · EZL
Pathway, LLC
Gastroenterology & Urology · 266d
Cleared Apr 21, 2020
Droplet Pen Needle 34G
K192082 · FMI
Htl-Strefa S.A
General Hospital · 263d
Cleared Apr 21, 2020
Galileo Vertebral Body Replacement Device
K192145 · PLR
Bright Spine
Orthopedic · 257d
Cleared Apr 21, 2020
EL CAPITAN Anterior Lumber Interbody System
K192492 · OVD
Astura Medical, LLC
Orthopedic · 223d
Cleared Apr 21, 2020
Globalcare Blood Pressure Monitor
K192609 · DXN
Globalcare Medical Technology Co., Ltd.
Cardiovascular · 214d
Cleared Apr 21, 2020
DIBS (Digital Indirect Bonding System)
K192701 · PNN
Orthoselect, LLC
Dental · 207d
Cleared Apr 21, 2020
Bevel Up Holder
K193074 · JKA
Nsp Tech Pte, Ltd.
General Hospital · 169d
Cleared Apr 21, 2020
Pristine Scope
K193161 · GCJ
Pristine Surgical
General & Plastic Surgery · 158d
Cleared Apr 21, 2020
NinesAI
K193351 · QAS
Nines, Inc.
Radiology · 140d
Cleared Apr 21, 2020
DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen...
K200053 · GCJ
Dannik
General & Plastic Surgery · 102d
Cleared Apr 21, 2020
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)
K200162 · GXY
Wuhan Greentek Pty , Ltd.
Neurology · 90d
Cleared Apr 21, 2020
Instylla Microcatheter
K200744 · KRA
Instylla, Inc.
Cardiovascular · 29d
Cleared Apr 21, 2020
Lariat, Hot/Cold Snare
K200745 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 29d