FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
8017–8040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 2024
Axial3D Cloud Segmentation Service
K231607 · LLZ
Axial Medical Printing Limited
Radiology · 237d
Cleared Jan 24, 2024
Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit
K231290 · DFH
The Binding Site, Ltd.
Immunology · 265d
Cleared Jan 23, 2024
2-Way 100% Silicone Cleartract Catheter
K233013 · EZL
Silq Technologies Corporation
Gastroenterology & Urology · 123d
Cleared Jan 23, 2024
Chemo Mouthpiece
K232917 · QUA
Chemo Mouthpiece, LLC
Dental · 126d
Cleared Jan 23, 2024
Dental Porcelain Powder
K232676 · EIH
Chengdu Besmile Medical Technology...
Dental · 144d
Cleared Jan 23, 2024
Dental Glass Ceramics
K232673 · EIH
Chengdu Besmile Medical Technology...
Dental · 144d
Cleared Jan 23, 2024
Endoform Dental Membrane
K231305 · NPL
Aroa Biosurgery , Ltd.
Dental · 263d
Cleared Jan 23, 2024
Nano-Check™ COVID-19 Antigen Test
K231187 · QVF
Nano-Ditech Corporation
Microbiology · 272d
Cleared Jan 23, 2024
SchurSign Tissue Marker
K230836 · NEU
Surgmark GmbH
General & Plastic Surgery · 302d
Cleared Jan 22, 2024
restor3d TIDAL Lumbar Interbody Fusion System
K234087 · MAX
Restor3d
Orthopedic · 31d
Cleared Jan 22, 2024
IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR,...
K233887 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 45d
Cleared Jan 22, 2024
MegaGen Dental Implant Abutment - Scan Healing Abutment
K233450 · NHA
Megagen Implant Co., Ltd.
Dental · 94d
Cleared Jan 22, 2024
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G,...
K231423 · NUH
Shenzhen Roundwhale Technology Co. ,...
Neurology · 250d
Cleared Jan 22, 2024
Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector
K231299 · PIO
Cair Lgl
Gastroenterology & Urology · 263d
Cleared Jan 22, 2024
NailLift
K230841 · MQZ
Jps Corporation
General & Plastic Surgery · 300d
Cleared Jan 20, 2024
RESPONSE™ Rib and Pelvic System
K233105 · MDI
OrthoPediatrics Corp.
Orthopedic · 115d
Cleared Jan 19, 2024
LifeSPARC System
K233736 · QNR
Cardiacassist, Inc.
Cardiovascular · 58d
Cleared Jan 19, 2024
SIGNA Champion
K233728 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 59d
Cleared Jan 19, 2024
Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)
K233461 · NUH
Hi-Dow International, Inc.
Neurology · 88d
Cleared Jan 19, 2024
IlluminOss Photodynamic Bone Stabilization System
K233436 · QAD
Illuminoss Medical, Inc.
Orthopedic · 98d
Cleared Jan 19, 2024
EndoSign® Cell collection device (ES-CYT-102)
K233142 · EOX
Cyted Limited
Gastroenterology & Urology · 114d
Cleared Jan 19, 2024
Power wheelchair (Model: JMPW-01W)
K232783 · ITI
Jiangsu Jumao X-Care Medical...
Physical Medicine · 130d
Cleared Jan 19, 2024
Cleaner™ Pro Thrombectomy System
K232679 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 140d
Cleared Jan 19, 2024
Electric Breast Pump, model: YM-8166
K232466 · HGX
Guangdong Youmeng Electrical...
Obstetrics & Gynecology · 157d