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
409–432 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Aug 24, 2026
TiLink-L™ SI Joint Fusion System
K261381 · OUR
SurGenTec, LLC
Orthopedic · 119d
Cleared Aug 24, 2026
BiWaze Clear System
K260604 · NHJ
Abmrc, LLC
Anesthesiology · 181d
Cleared Aug 24, 2026
SEISMIQ™ Intravascular Lithotripsy System
K260246 · PPN
Bolt Medical, Inc.
Cardiovascular · 209d
Cleared Aug 24, 2026
OsteoCoil™ GT Active Compression System
K260106 · HWC
Flower Orthopedics Corporation DBA...
Orthopedic · 222d
Cleared Aug 24, 2026
Guided Bone Regeneration System
K254286 · DZL
DentalMaster(Xiamen)Medical...
Dental · 236d
Cleared Aug 24, 2026
Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo...
K254027 · IYN
Sonoscape Medical Corp.
Radiology · 251d
Cleared Aug 24, 2026
Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments
K253515 · JDI
Biomet Orthopedics, Inc.
Orthopedic · 290d
Cleared Aug 23, 2026
BTL-699
K260691 · OBP
BTL Industries, Inc.
Neurology · 173d
Cleared Aug 22, 2026
Stitch - Suture Wires and Tapes
K253910 · GAT
GM Dos Reis Industria e Comercio Ltda.
General & Plastic Surgery · 257d
Cleared Aug 21, 2026
Artix™ MT
K262538 · QEW
Inari Medical, Inc.
Cardiovascular · 29d
Cleared Aug 21, 2026
DS Core CBCT Anatomy
K262127 · QIH
Dentsply Sirona
Radiology · 58d
Cleared Aug 21, 2026
Disposable Warming Blanket
K262089 · DWJ
Hangzhou Tappa Medical Technology...
Cardiovascular · 60d
Cleared Aug 21, 2026
Any-Zircos
K262074 · EIH
Mediclus Co., Ltd.
Dental · 60d
Cleared Aug 21, 2026
Affera Integrated Mapping System
K262005 · DQK
Medtronic, Inc.
Cardiovascular · 67d
Cleared Aug 21, 2026
Pisces-SC Standalone Cervical Interbody System
K261882 · OVE
Osseus Fusions Systems, LLC
Orthopedic · 77d
Cleared Aug 21, 2026
AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors
K261710 · QPB
Apyx Medical Corporation
General & Plastic Surgery · 91d
Cleared Aug 21, 2026
Alegria Flash MPO
K261466 · MOB
Zeus Scientific
Immunology · 109d
Cleared Aug 21, 2026
Electric wheelchair (D03)
K261354 · ITI
Foshan Sowell Medical Technology Co.,...
Physical Medicine · 119d
Cleared Aug 21, 2026
Solo Scope Colonoscope System
K261015 · FDF
Gi View , Ltd.
Gastroenterology & Urology · 147d
Cleared Aug 21, 2026
Cimilre Dual Max
K260643 · HGX
Cimilre Co., Ltd.
Obstetrics & Gynecology · 175d
Cleared Aug 21, 2026
BoneMRI
K260584 · QIH
Mriguidance B.V.
Radiology · 182d
Cleared Aug 21, 2026
IDS SS-A/Ro
K253817 · LLL
Immunodiagnostics Systems Limited
Immunology · 266d
Cleared Aug 21, 2026
EVOLUTION® AM BIOFOAM® Tibial System
K253728 · MBH
Microport Orthopedics, Inc.
Orthopedic · 270d
Cleared Aug 21, 2026
uAngio AVIVA CX
K253726 · OWB
Shanghai United Imaging Healthcare...
Radiology · 270d