FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,922 results
97–120 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jul 24, 2026
DiscreetDuo™ Flow Wearable Breast Pump (Model S3)
K260259 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 177d
Cleared Jul 24, 2026
DIANA
K260192 · QIH
ROPCA ApS
Radiology · 183d
Cleared Jul 24, 2026
PerfusiX-Imaging
K254180 · OWN
LIMIS Development B.V.
Gastroenterology & Urology · 213d
Cleared Jul 24, 2026
Tiger 2 System
K253943 · NKB
Zavation Medical Products, LLC
Orthopedic · 226d
Cleared Jul 24, 2026
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
K253703 · FRN
Deka R&D Corp
General Hospital · 242d
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