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
15625–15648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K210943 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 237d
Cleared Nov 22, 2021
Non-sterile Powder Free Nitrile Examination Gloves
K210990 · LZA
Rubberex Alliance Sdn Bhd
General Hospital · 234d
Cleared Nov 22, 2021
Philips Incisive CT on Trailer
K211168 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 217d
Cleared Nov 22, 2021
Eclipse PRO
K211651 · MWJ
Spacelabs Healthcare, Ltd.
Cardiovascular · 178d
Cleared Nov 22, 2021
Pre-Formed Extra Support Guidewire
K211741 · DQX
Lake Region Medical
Cardiovascular · 168d
Cleared Nov 22, 2021
VITA Akzent LC
K211854 · EBD
Vita Zahnfabrik GmbH H Rauter & CO
Dental · 159d
Cleared Nov 22, 2021
Agile Esophageal OTW Stent System
K211960 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 151d
Cleared Nov 22, 2021
Low-frequency Stimulator (Model: AST-645, AST-646)
K212989 · NUH
Shenzhen Osto Technology Co., Ltd.
Neurology · 63d
Cleared Nov 22, 2021
Spartan MC 0165
K213451 · QJP
Spartan Micro
Neurology · 27d
Cleared Nov 19, 2021
Finebeam
K202288 · GEX
Snj Co., Ltd.
General & Plastic Surgery · 464d
Cleared Nov 19, 2021
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile...
K203074 · LYY
Pt. Universal Gloves
General Hospital · 406d
Cleared Nov 19, 2021
Velofix SA Cervical Cage
K210573 · OVE
U&I Corporation
Orthopedic · 266d
Cleared Nov 19, 2021
OnQ Neuro
K210831 · QIH
Cortechs Labs, Inc.
Radiology · 245d
Cleared Nov 19, 2021
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
K211032 · KOD
Urogen Pharma, Ltd.
Gastroenterology & Urology · 226d
Cleared Nov 19, 2021
HALYARD Flexaprene Green Powder-Free Exam Glove
K211063 · LZA
O&M Halyard, Inc.
General Hospital · 224d
Cleared Nov 19, 2021
EkoSonic Endovascular Device
K211080 · QEY
Boston Scientific
Cardiovascular · 221d
Cleared Nov 19, 2021
EndoScreener
K211326 · QNP
Chengdu Wision Medical Device Co., Ltd.
Gastroenterology & Urology · 203d
Cleared Nov 19, 2021
BD Nano 2nd Gen Pen Needle
K212015 · FMI
Becton, Dickinson and Company
General Hospital · 144d
Cleared Nov 19, 2021
Catalyft LS Expandable Interbody System
K212653 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Nov 19, 2021
Disposable Nitrile Examination Glove
K212661 · LZA
Inner Mongolia Cureguard Medical...
General Hospital · 88d
Cleared Nov 19, 2021
MR 5300
K212673 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 87d
Cleared Nov 19, 2021
Leaf Smooth
K212697 · OHT
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Nov 19, 2021
Frontier Series Power Wheelchairs
K213090 · ITI
Magic Mobility
Physical Medicine · 56d
Cleared Nov 19, 2021
Arthrex Vortex Threaded Bone Marrow Recovery Needle
K213213 · KNW
Arthrex, Inc.
General & Plastic Surgery · 51d