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: Cleared only ×
175,230 results
73–96 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 2026
METICULY Patient-specific CMF solution
K253206 · JEY
Meticuly Co., Ltd.
Dental · 302d
Cleared Jul 24, 2026
TheraSphere 360™ Y-90 Management Platform
K262462 · LLZ
Boston Scientific Corporation
Radiology · 7d
Cleared Jul 24, 2026
LumenCare Azure
K262383 · JAQ
Nucletron B.V.
Radiology · 11d
Cleared Jul 24, 2026
dS FootAnkle 16Ch 1.5T
K262294 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 17d
Cleared Jul 24, 2026
REMEDY POLY+PLUS SNAP FIT Acetabular Cup
K262290 · KWL
Osteoremedies, LLC
Orthopedic · 18d
Cleared Jul 24, 2026
FARADRIVE™ Steerable Sheath (M004PF21M402)
K262165 · DRA
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Jul 24, 2026
VS-370CF, VS-370CT
K262152 · FCX
VISION MEDICAL Co., Ltd.
Gastroenterology & Urology · 29d
Cleared Jul 24, 2026
Ion-L Navigated Instruments
K262121 · OLO
SurGenTec, LLC
Orthopedic · 31d
Cleared Jul 24, 2026
VERAFEYE Imaging Catheter (VF-VIC-002)
K261849 · OBJ
Luma Vision Limited
Cardiovascular · 51d
Cleared Jul 24, 2026
Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60
K261781 · JTN
Thermo Fisher Scientific (Oxoid Ltd.)
Microbiology · 56d
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 · FCG
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