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
529–552 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Aug 10, 2026
Icona Hip Stem
K261576 · MEH
Corin, Ltd.
Orthopedic · 90d
Cleared Aug 10, 2026
Mobility Scooter (W3483, W3483A)
K260176 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 201d
Cleared Aug 10, 2026
Unimpregnated Central Venous Catheter
K260165 · FOZ
Spectrum Vascular
General Hospital · 202d
Cleared Aug 10, 2026
Mobility Scooter (W3465, W3902 (S50 Carbon))
K260094 · INI
Zhejiang Innuovo Rehabilitation...
Physical Medicine · 209d
Cleared Aug 10, 2026
EM-TECH Passive Ultrasound Probe Strap
K254143 · ITX
EM-TECH Solutions, Inc.
Radiology · 231d
Cleared Aug 10, 2026
Hemoclip (511 series, 543 series)
K254069 · PKL
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 235d
Cleared Aug 10, 2026
Novii+ Wireless Patch System
K254036 · HGM
Datex-Ohmeda, Inc.
Obstetrics & Gynecology · 237d
Cleared Aug 10, 2026
Prostate Core
K253794 · QIH
Lucida Medical, Ltd.
Radiology · 255d
Cleared Aug 10, 2026
Atellica IM CA 19-9 II
K253528 · NIG
Siemens Healthcare Diagnostics, Inc.
Immunology · 270d
Cleared Aug 10, 2026
Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)
K253468 · MPA
Nova Eye, Inc.
Ophthalmic · 305d
Cleared Aug 07, 2026
Arthrex Bioabsorbable PushLock Suture Anchors
K262357 · MAI
Arthrex, Inc.
Orthopedic · 28d
Cleared Aug 07, 2026
PacTemp Automix NE
K261937 · EMA
The Belport Company Inc., DBA Gingi-Pak
Dental · 58d
Cleared Aug 07, 2026
BUM Oil
K261905 · NUC
Bumlicious, LLC (DBA “Bumlicious”)
Obstetrics & Gynecology · 60d
Cleared Aug 07, 2026
Venue Go
K261668 · IYN
GE Medical Systems Ultrasound and...
Radiology · 79d
Cleared Aug 07, 2026
LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
K261601 · OHS
Shenzhen Chuangtong Yigou Technology...
General & Plastic Surgery · 85d
Cleared Aug 07, 2026
Freedom Total Knee System (E-Poly Tibial Liners)
K261563 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 88d
Cleared Aug 07, 2026
Mistral-Air® Warming System
K261437 · DWJ
The Surgical Company International...
Cardiovascular · 99d
Cleared Aug 07, 2026
Xpert Hemorrhagic Fever
K261362 · QVR
Cepheid
Microbiology · 102d
Cleared Aug 07, 2026
Surgical Gown Level2 (S, M, L, XL, XXL, XXXL)
K261028 · FYA
Yadu Medical (Henan) Co., Ltd.
General Hospital · 130d
Cleared Aug 07, 2026
Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R,...
K260933 · FMI
Hangzhou Qiantang Longyue...
General Hospital · 140d
Cleared Aug 07, 2026
EW10-EC02 Endoscopy Support Program
K260567 · QNP
Fujifilm Corporation
Gastroenterology & Urology · 169d
Cleared Aug 07, 2026
Zenition 30
K254205 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 221d
Cleared Aug 07, 2026
Intuitive Endoluminal Gastrointestinal System (IG1000)
K253702 · FDS
Intuitive Surgical, Inc.
Gastroenterology & Urology · 256d
Cleared Aug 07, 2026
Aperio iQC DX Software
K253561 · SIX
Leica Biosystems Imaging, Inc.
Pathology · 263d