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
16177–16200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2021
Unifine SafeControl
K210399 · FMI
Owen Mumford, Ltd.
General Hospital · 219d
Cleared Sep 17, 2021
Incontinence Probe
K210441 · KPI
Shenzhen Med-Link Electronics Tech...
Gastroenterology & Urology · 217d
Cleared Sep 17, 2021
NTI ClenchGuard
K211158 · OBR
Boyd Research, Inc.
Dental · 151d
Cleared Sep 17, 2021
RedEx
K211234 · GCJ
Advanced Surgical Concepts, Ltd.
General & Plastic Surgery · 147d
Cleared Sep 17, 2021
WELLTRUST WT-III Mask with Flat Earloop
K211751 · FXX
Lonestar Meadows, LLC
General Hospital · 102d
Cleared Sep 17, 2021
Vinyl Glove
K211904 · LYZ
Jiangsu Dihong Industry and Trade...
General Hospital · 88d
Cleared Sep 17, 2021
Deep Learning Image Reconstruction
K212067 · JAK
Ge Healthcare Japan Corporation
Radiology · 77d
Cleared Sep 17, 2021
Intelligent NR
K212269 · MQB
Canon, Inc.
Radiology · 59d
Cleared Sep 17, 2021
Tempo Natural Tampon
K212272 · HEB
Dong-A Pharmaceutical Co., Ltd.
Obstetrics & Gynecology · 59d
Cleared Sep 16, 2021
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
K203111 · DTZ
Medtronic
Cardiovascular · 336d
Cleared Sep 16, 2021
Disposable Medical Mask
K203112 · FXX
Yangzhou Runyi Arts & Crafts Co., Ltd.
General Hospital · 336d
Cleared Sep 16, 2021
Sterile Latex Surgical Gloves Powder Free
K211478 · KGO
Aspen Glove Sdn. Bhd.
General Hospital · 127d
Cleared Sep 16, 2021
Blue Nitrile Examination Glove Powder Free
K211479 · LZA
Aspen Glove Sdn. Bhd.
General Hospital · 127d
Cleared Sep 16, 2021
VISIONAIRE UK Patient Matched Cutting Guides
K211512 · HSX
Smith & Nephew, Inc.
Orthopedic · 125d
Cleared Sep 16, 2021
6430 MyLabX75, 6430 MyLab XPro75
K212021 · IYN
Esaote, S.P.A.
Radiology · 80d
Cleared Sep 16, 2021
BioRoot Flow 0.5g, BioRoot Flow 2g
K212283 · KIF
Septodont
Dental · 57d
Cleared Sep 16, 2021
Symbia VA10A Family
K212604 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Sep 16, 2021
StrataMR II Valves and Shunts
K212641 · JXG
Medtronic Neurosurgery
Neurology · 27d
Cleared Sep 16, 2021
GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System...
K212742 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 17d
Cleared Sep 15, 2021
RXS 1000
K202369 · MUH
Rolence Enterprise, Inc.
Radiology · 392d
Cleared Sep 15, 2021
GlucoSure HT Plus Blood Glucose Monitoring System
K202885 · NBW
Apex BioTechnology Corp.
Chemistry · 352d
Cleared Sep 15, 2021
Instrument tray, for semi-rigid ureteroscope
K203492 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 300d
Cleared Sep 15, 2021
TruAbutment DS, TruBase
K203649 · NHA
Truabutment, Inc.
Dental · 275d
Cleared Sep 15, 2021
HealthCCSng
K210085 · JAK
Zebra Medical Vision, Ltd.
Radiology · 245d