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
16513–16536 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2021
First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First...
K210327 · QBF
W.H.P.M., Inc.
Toxicology · 189d
Cleared Aug 12, 2021
Disposable Surgical Gown
K210510 · FYA
Shandong Zhushi Pharmaceutical Group...
General Hospital · 171d
Cleared Aug 12, 2021
SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset
K210661 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 161d
Cleared Aug 12, 2021
Excelsius3D
K210912 · OWB
Globus Medical, Inc.
Radiology · 136d
Cleared Aug 12, 2021
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices,...
K210946 · KNW
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 135d
Cleared Aug 12, 2021
InferRead CT Stroke.AI
K211179 · QAS
Infervision Medical Technology Co., Ltd.
Radiology · 114d
Cleared Aug 12, 2021
Prase-C Anterior Cervical Plate System
K211205 · KWQ
Gbs Commonwealth Co., Ltd.
Orthopedic · 112d
Cleared Aug 12, 2021
eVolve PACS
K211863 · LLZ
Evolve Pacs, Inc.
Radiology · 57d
Cleared Aug 12, 2021
VERTICALE Navigation Instruments
K212007 · OLO
Silony Medical GmbH
Orthopedic · 45d
Cleared Aug 11, 2021
Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis...
K202536 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 344d
Cleared Aug 11, 2021
Disposable Face Mask
K203152 · FXX
Chaozhou Cecilia Technology Co., Ltd.
General Hospital · 293d
Cleared Aug 11, 2021
uCT ATLAS with uWS-CT-Dual Energy Analysis
K203448 · JAK
Shanghai United Imaging Healthcare...
Radiology · 261d
Cleared Aug 11, 2021
Sensatronic Reusable Temperature Probes
K203643 · FLL
Sensatronic GmbH
General Hospital · 240d
Cleared Aug 11, 2021
CONTOUR® NEXT ONE Blood Glucose Monitoring System
K210687 · NBW
Ascensia Diabetes Care
Chemistry · 156d
Cleared Aug 11, 2021
Solo, Swing Maxi
K210759 · HGX
Medela, LLC
Obstetrics & Gynecology · 149d
Cleared Aug 11, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System
K211102 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 120d
Cleared Aug 11, 2021
Medical Face Mask
K211353 · FXX
Shenzhen Lyttop Healthcare Limited
General Hospital · 100d
Cleared Aug 11, 2021
Surgical mask
K211552 · FXX
Shandong Shengquan New Materials Co.,...
General Hospital · 84d
Cleared Aug 11, 2021
QUANTUM® Patient Specific Instrumentation (PSI) System
K211883 · HSN
In2bones Sas
Orthopedic · 51d
Cleared Aug 11, 2021
Z-LINKPC System
K211993 · NKG
Zavation Medical Products, LLC
Orthopedic · 44d
Cleared Aug 11, 2021
Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha...
K212204 · QGN
Cd Diagnostics, Inc.
Microbiology · 27d
Cleared Aug 10, 2021
sOLVe Tube
K201026 · CBI
Hytek Medical, Inc.
Anesthesiology · 477d
Cleared Aug 10, 2021
Nitrile Patient Examination Glove
K210730 · LZA
American Performance Polymers, LLC
General Hospital · 152d
Cleared Aug 10, 2021
EAGLE EDGE AXR90 and AXR120
K210820 · OAS
Alliage S/A Industrias Medico...
Radiology · 144d