FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,642 results
1129–1152 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Mar 06, 2026
Bunkerhill Contrast AVC
K260167 · JAK
BunkerHill Health
Radiology · 45d
Cleared Mar 06, 2026
Bunkerhill Contrast CAC
K260166 · JAK
BunkerHill Health
Radiology · 45d
Cleared Mar 06, 2026
CVAC Image Processor
K260013 · FGB
Calyxo, Inc.
Gastroenterology & Urology · 60d
Cleared Mar 06, 2026
Water-based lubricant
K253983 · NUC
Guangzhou Haoyimai Trading Co., Ltd.
Obstetrics & Gynecology · 84d
Cleared Mar 06, 2026
Holmium Laser Therapeutic Apparatus (HZ-A)
K253951 · GEX
Guangzhou Potent Medical Equipment...
General & Plastic Surgery · 86d
Cleared Mar 06, 2026
Velocity Alpha MR High Speed Surgical Drill System
K253772 · HBB
Adeor Medical AG
Neurology · 100d
Cleared Mar 06, 2026
VELYS™ Hip Navigation
K253551 · QIH
Depuy Ireland UC
Radiology · 112d
Cleared Mar 06, 2026
TeKBrace Knotless Anchor
K253538 · MBI
Theramicro
Orthopedic · 113d
Cleared Mar 06, 2026
EmeryGlide™ (EG18008901)
K253262 · DQX
Nano4imaging GmbH
Cardiovascular · 158d
Cleared Mar 06, 2026
Single use stone retrieval balloons
K253132 · FGE
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 162d
Cleared Mar 06, 2026
JFord Speculum Sleeve™
K252208 · HIB
Ford Medtech, LLC
Obstetrics & Gynecology · 234d
Cleared Mar 06, 2026
BONTREE PLUS
K251818 · LYC
Hudens Bio Co., Ltd.
Dental · 266d
Cleared Mar 06, 2026
Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
K251807 · KGE
Olympus Medical Systems Corp.
Gastroenterology & Urology · 267d
Cleared Mar 05, 2026
AV Cardiac CT
K260169 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 44d
Cleared Mar 05, 2026
Phantom® Hindfoot TTC/TC Nail System
K253591 · HSB
Paragon 28, Inc.
Orthopedic · 108d
Cleared Mar 05, 2026
EarliPoint Assessment
K253442 · QPF
Earlitec Diagnostics
Neurology · 155d
Cleared Mar 05, 2026
CORIS System
K253267 · SEW
Nanosonics Limited
General Hospital · 157d
Cleared Mar 05, 2026
YUWELL® Electronic Blood Pressure Monitor (YE630CR)
K252779 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 184d
Cleared Mar 05, 2026
CEPHX3D
K252538 · QIH
Orca Dental AI , Ltd.
Radiology · 205d
Cleared Mar 05, 2026
Adhese 2
K252450 · KLE
Ivoclar Vivadent, Inc.
Dental · 213d
Cleared Mar 05, 2026
Arthrex FibuLock Nail System
K252196 · HSB
Arthrex, Inc.
Orthopedic · 234d
Cleared Mar 05, 2026
Magnifico Open (100009900)
K251901 · LNH
Esaote, S.P.A.
Radiology · 258d
Cleared Mar 05, 2026
Extension tube
K251788 · DXT
Zhuhai DR Medical Instruments Co., Ltd.
General Hospital · 267d
Cleared Mar 04, 2026
Mendit
K260380 · PBQ
Escala Medical, Ltd.
Obstetrics & Gynecology · 27d