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
8617–8640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 19, 2024
MagnetOs Granules
K232347 · MQV
Kuros Biosciences B.V
Orthopedic · 168d
Cleared Jan 19, 2024
Rapid ASPECTS (v3)
K232156 · POK
Ischemaview, Inc.
Radiology · 183d
Cleared Jan 19, 2024
DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix...
K231873 · MEH
Depuy Ireland UC
Orthopedic · 207d
Cleared Jan 19, 2024
BD Vacutainer® Fluoride Blood Collection Tubes
K231237 · JKA
Becton, Dickinson and Company
Chemistry · 266d
Cleared Jan 19, 2024
Distal Access Catheter
K231218 · QJP
Accumedical Beijing , Ltd.
Neurology · 266d
Cleared Jan 19, 2024
HKT Anatomical Locking Trauma System
K231213 · HRS
Hankil Tech Medical Co., Ltd.
Orthopedic · 266d
Cleared Jan 19, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel
K231192 · NBW
Bionime Corporation
Chemistry · 267d
Cleared Jan 19, 2024
Mix2Vial® Transfer Device
K231071 · LHI
West Pharma Services Il, Ltd.
General Hospital · 280d
Cleared Jan 19, 2024
TORPEDO Implant System®
K230817 · OUR
Deltacor GmbH
Orthopedic · 301d
Cleared Jan 19, 2024
Cold Compression Wrap Pro
K230524 · IRP
Chengdu Cryo-Push Medical Technology...
Physical Medicine · 326d