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

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175,820 results
673–696 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2026
OBSIDIO Conformable Embolic
K261488 · KRD
Boston Scientific Corporation
Cardiovascular · 79d
Cleared Jul 24, 2026
Atellica CH Acetaminophen 2 (ACTM)
K261364 · LDP
Siemens Healthcare Diagnostics, Inc.
Chemistry · 88d
Cleared Jul 24, 2026
SwiftMR
K261349 · QIH
Airs Medical, Inc.
Radiology · 91d
Cleared Jul 24, 2026
Temporary Keratoprosthesis (QuickSet TKP™)
K261312 · MLP
Eyekon Medical, Inc.
Ophthalmic · 94d
Cleared Jul 24, 2026
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes
K261274 · KTI
Cook Ireland, Ltd.
Anesthesiology · 98d
Cleared Jul 24, 2026
Careflux H60
K261267 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 99d
Cleared Jul 24, 2026
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium...
K261221 · GEX
Olympus Surgical Technologies America
Gastroenterology & Urology · 101d
Cleared Jul 24, 2026
NOVEOS Specific IgE (sIgE)
K261027 · DHB
Hycor Biomedical
Immunology · 116d
Cleared Jul 24, 2026
TMINI Miniature Robotic System
K261024 · OLO
THINK Surgical, Inc.
Orthopedic · 116d
Cleared Jul 24, 2026
Accuro® 3S Needle Guide Kit
K261014 · ITX
Rivanna Medical, Inc.
Radiology · 119d
Cleared Jul 24, 2026
Air Compression Massager (EP30B001 I)
K260948 · IRP
Wavepulse (Xiamen) Healthcare...
Physical Medicine · 123d
Cleared Jul 24, 2026
5 Wavelength LED Facemask (TN2508)
K260598 · OHS
iSMART Developments, Ltd.
General & Plastic Surgery · 150d
Cleared Jul 24, 2026
QUATTRO Spinal system (Open Configuration)
K260362 · NKB
MANTIZ Co., Ltd.
Orthopedic · 170d
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