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
193–216 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Sep 16, 2026
GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05,...
K261467 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 135d
Cleared Sep 16, 2026
Ambu® aScope™ Gastro
K261400 · FDS
Ambu A/S
Gastroenterology & Urology · 140d
Cleared Sep 16, 2026
LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))
K261370 · NFO
Guangdong Newdermo Biotech Co., Ltd.
Neurology · 142d
Cleared Sep 16, 2026
APERTO Lucent MRI System
K261283 · LNH
Fujifilm Corporation
Radiology · 152d
Cleared Sep 16, 2026
a2z-Abdo-Triage
K260906 · QAS
A2z Radiology Ai, Inc.
Radiology · 181d
Cleared Sep 16, 2026
Ambu® aScope™ 5 Broncho 2.7/1.2
K260309 · EOQ
Ambu A/S
Ear, Nose, Throat · 229d
Cleared Sep 16, 2026
ElintMAX Respiratory Monitor (ElintMAX Monitor A1)
K260226 · BZK
Amptron Medical, Inc.
Anesthesiology · 233d
Cleared Sep 16, 2026
Route 92 Medical Full Length 046 Access System
K260220 · QJP
Route 92 Medical, Inc.
Neurology · 233d
Cleared Sep 16, 2026
NC PTA Balloon Dilatation Catheter
K254212 · LIT
Kossel Medtech (Suzhou) Co., Ltd.
Cardiovascular · 261d
Cleared Sep 16, 2026
Aristotle 65 Macrowire
K254181 · MOF
Scientia Vascular
Neurology · 267d
Cleared Sep 16, 2026
Dia-X Sil Light Body
K254152 · ELW
DiaDent Group International
Dental · 268d
Cleared Sep 16, 2026
Dia-X Sil Heavy Body
K254142 · ELW
DiaDent Group International
Dental · 268d
Cleared Sep 15, 2026
TMC Implant Fixation System
K262963 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 21d
Cleared Sep 15, 2026
GMK Extension
K262057 · JWH
Medacta International, SA
Orthopedic · 89d
Cleared Sep 15, 2026
SPINEsim v1.0
K261861 · LLZ
Mdsim S.A.
Radiology · 103d
Cleared Sep 15, 2026
Artificial Intelligence Renal Assessment (AIRA) Version 1
K261677 · QIH
Aramis Global AI Consultancies, LLC
Radiology · 117d
Cleared Sep 15, 2026
CVAC® Aspiration System
K261447 · FGB
Calyxo, Inc.
Gastroenterology & Urology · 137d
Cleared Sep 15, 2026
LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
K261070 · GEI
Covidien, LLC
General & Plastic Surgery · 167d
Cleared Sep 15, 2026
Tontarra Punches and Rongeurs
K260446 · HAE
Tontarra Medizintechnik GmbH
Neurology · 216d
Cleared Sep 15, 2026
YJ-K1K2 Wheelchair (YJ-013F)
K260145 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 238d
Cleared Sep 15, 2026
Reclining wheelchair (YJ-013L)
K260144 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 238d
Cleared Sep 15, 2026
Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
K260141 · IOR
Zhenjiang Assure Medical Equipment...
Physical Medicine · 238d
Cleared Sep 15, 2026
CLEARVISION Irrigation Sheath 0° (7241AS)
K254299 · EOB
Karl Storz SE & CO. KG
Ear, Nose, Throat · 258d
Cleared Sep 15, 2026
OOOPDS
K254214 · LLZ
Taiwan Main Orthopaedic Biotechnology...
Radiology · 260d