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
697–720 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 24, 2026
EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing...
K253541 · GCJ
Medical Impact
General & Plastic Surgery · 252d
Cleared Jul 24, 2026
Accuro 3S
K253452 · IYO
Rivanna Medical, Inc.
Radiology · 291d
Cleared Jul 24, 2026
GEN 4 JOY Wheelchair
K252370 · IOR
Free Wheelchair Mission
Physical Medicine · 359d
Cleared Jul 23, 2026
ImageGrid StreamVue
K262143 · LLZ
Candelis, Inc.
Radiology · 28d
Cleared Jul 23, 2026
TRUE METRIX Self Monitoring Blood Glucose System
K262116 · NBW
Trividia Health, Inc.
Chemistry · 30d
Cleared Jul 23, 2026
Gepotidacin GEP 10 µg
K261853 · JTN
Liofilchem, Inc.
Microbiology · 50d
Cleared Jul 23, 2026
Dental Cone-beam Computed Tomography (mDX-15P Series)
K261748 · OAS
Hefei Meyer Optoelectronic...
Radiology · 56d
Cleared Jul 23, 2026
Klassic Infection Spacer System
K261734 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 58d
Cleared Jul 23, 2026
CORE 300 Digital Stethoscope
K261694 · DQD
Eko Health, Inc.
Cardiovascular · 62d
Cleared Jul 23, 2026
Perfadex Plus
K261644 · KDN
Xvivo Perfusion AB
Gastroenterology & Urology · 66d
Cleared Jul 23, 2026
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/...
K261272 · IYN
Esonic Technology (Wuhan) Co., Ltd.
Radiology · 97d
Cleared Jul 23, 2026
Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
K261136 · DXN
Guangzhou Daxin Health Technology...
Cardiovascular · 107d
Cleared Jul 23, 2026
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
K261082 · DXN
Microlife Corporation
Cardiovascular · 113d
Cleared Jul 23, 2026
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
K261081 · IYN
Beijing Konted Medical Technology...
Radiology · 113d
Cleared Jul 23, 2026
VELMENI for DENTISTS (V4D) 3D
K254096 · QIH
Velmeni, Inc.
Radiology · 216d
Cleared Jul 23, 2026
FACEGYM Pro Device (HD-109)
K253932 · NFO
Shenzhen Kaiyan Medical Equipment...
Neurology · 226d
Cleared Jul 23, 2026
RXiBreeze PAP System (RXiBreeze 20C)
K253044 · BZD
Resvent Medical Technology Co., Ltd.
Anesthesiology · 304d
Cleared Jul 23, 2026
3d Cage Cervical
K253041 · ODP
Fims Co., Ltd.
Orthopedic · 304d
Cleared Jul 22, 2026
Lancet
K262211 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 22d
Cleared Jul 22, 2026
E3D™-C Interbody System
K262094 · OVE
Evolution Spine
Orthopedic · 30d
Cleared Jul 22, 2026
PreludeSYNC™ Radial Compression Device
K262086 · DXC
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jul 22, 2026
Lapidus Screw Kit
K262075 · HWC
Relja Innovations, LLC
Orthopedic · 30d
Cleared Jul 22, 2026
AlphaTriPart - Monopolar MIC Instruments
K261179 · GEI
Gimmi GmbH
General & Plastic Surgery · 103d
Cleared Jul 22, 2026
Op.n™ Spine Navigation and Robotic Guidance
K261113 · OLO
Ecential Robotics
Orthopedic · 110d