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

Filters: 2026–2026 ×
2,517 results
577–600 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Aug 05, 2026
CAD - Lower GI (EC07-01)
K252853 · QNP
Xiamen Inno Medical Technology Co., Ltd.
Gastroenterology & Urology · 331d
Cleared Aug 04, 2026
Alturion Series Diagnostic Ultrasound System
K262311 · IYN
Philips Ultrasound, LLC
Radiology · 27d
Cleared Aug 04, 2026
Navigator™ Flex Ureteral Access Sheath Set
K261915 · FED
Boston Scientific Corporation
Gastroenterology & Urology · 56d
Cleared Aug 04, 2026
LED Light Therapy Mask (JML1, JML1+JML2)
K261851 · OHS
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 62d
Cleared Aug 04, 2026
Freedom Partial Knee System
K261609 · HSX
Maxx Orthopedics, Inc.
Orthopedic · 82d
Cleared Aug 04, 2026
Vertex™ Thrombectomy System
K261523 · QEW
Jupiter Endovascular
Cardiovascular · 89d
Cleared Aug 04, 2026
LED Light Therapy Masks (PE748, PE749, PE756)
K261496 · OHS
Duplex International Trading Limited
General & Plastic Surgery · 90d
Cleared Aug 04, 2026
Marrow Marxman
K260572 · KNW
Medimetrix, LLC
General & Plastic Surgery · 166d
Cleared Aug 04, 2026
TRIVANCE™ Hip Stem
K254043 · LPH
Globus Medical, Inc.
Orthopedic · 230d
Cleared Aug 04, 2026
RealGUIDE
K253902 · QIH
3DIEMME SRL
Radiology · 242d
Cleared Aug 04, 2026
OMNI Ultra Surgical System (1-110)
K253760 · MRH
Sight Sciences, Inc.
Ophthalmic · 252d
Cleared Aug 03, 2026
VueJect® Ultrasound Enhancing Agent Delivery System
K262115 · IZQ
Acist Medical Systems, Inc.
General Hospital · 41d
Cleared Aug 03, 2026
Grappler Suture Anchor System
K262047 · MBI
Paragon 28, Inc.
Orthopedic · 46d
Cleared Aug 03, 2026
Halcyon, Ethos Radiotherapy System (5.0)
K261856 · IYE
Varian Medical Systems, Inc.
Radiology · 60d
Cleared Aug 03, 2026
PuraStat-RM
K261504 · PHN
3-D Matrix, Inc.
Gastroenterology & Urology · 89d
Cleared Aug 03, 2026
PuraStat GI
K261503 · QAU
3-D Matrix, Inc.
General & Plastic Surgery · 89d
Cleared Aug 03, 2026
SABER-XA System
K261408 · OVD
Elevation Spine
Orthopedic · 95d
Cleared Aug 03, 2026
Eve
K260381 · PHL
Wandercraft SAS
Neurology · 179d
Cleared Aug 03, 2026
XLITE
K260236 · IZL
GEMSS HEALTHCARE CO., LTD.
Radiology · 189d
Cleared Jul 31, 2026
NanoCeram Resin
K262681 · EBI
3BFAB TEKNOLOJI A.S.
Dental · 1d
Cleared Jul 31, 2026
Lantern Knee Navigation Unit (406000-03)
K262253 · ONN
Orthalign, Inc.
Orthopedic · 29d
Cleared Jul 31, 2026
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial...
K262251 · JWH
Globus Medical, Inc.
Orthopedic · 30d
Cleared Jul 31, 2026
SnØreNegatØr
K261912 · LRK
DnB Innovations, LLC
Dental · 53d
Cleared Jul 31, 2026
xvision Spine system
K261854 · SBF
Augmedics, Ltd.
Orthopedic · 58d