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
769–792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 14, 2026
Invictus® Small Stature Spinal Fixation System
K261284 · NKB
Alphatec Spine, Inc.
Orthopedic · 88d
Cleared Jul 14, 2026
Universal Seal (5-12 mm)
K261249 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 89d
Cleared Jul 14, 2026
IERO Mobility Scooter (IERO-01)
K261232 · INI
Jochu Technology Co., Ltd.
Physical Medicine · 90d
Cleared Jul 14, 2026
Symmetrix™ L Spinal System
K261020 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 109d
Cleared Jul 14, 2026
Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US,...
K260578 · GXY
Ambu A/S
Neurology · 144d
Cleared Jul 14, 2026
Accoat Guide Wire
K253667 · DQX
Sp Medical A/S
Cardiovascular · 235d
Cleared Jul 14, 2026
LIXI (LXOSFM1)
K253662 · MSC
Luwi, LLC
Obstetrics & Gynecology · 236d
Cleared Jul 13, 2026
Merit MAK Nitinol/Gold-Tungsten Guide Wire
K261640 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 56d
Cleared Jul 13, 2026
Wearable Breast Pump (Model S32A)
K261199 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 91d
Cleared Jul 13, 2026
Rapid Vessel Occlusion (Rapid VO)
K261085 · QAS
Ischemaview
Radiology · 103d
Cleared Jul 13, 2026
Ultra-Fine™ SAFETY Insulin Syringe
K260208 · FMF
embecta Medical II, LLC
General Hospital · 171d
Cleared Jul 13, 2026
SLIM Microcatheter
K260199 · QJP
Balt USA, LLC
Neurology · 172d
Cleared Jul 13, 2026
Hearing assist
K254044 · SCR
Meta Platform Technologies, LLC
Ear, Nose, Throat · 208d
Cleared Jul 13, 2026
Volnewmer™
K253504 · GEI
Classys, Inc.
General & Plastic Surgery · 255d
Cleared Jul 10, 2026
Avara Viewer
K262120 · LLZ
Avara Software
Radiology · 17d
Cleared Jul 10, 2026
WallFlex Esophageal Stent System
K261978 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 28d
Cleared Jul 10, 2026
NYES Tuff Cuff L3 Disposable Gowns
K261949 · FYA
New York Embroidery Studio
General Hospital · 29d
Cleared Jul 10, 2026
Omnifit® 20° Series I Insert
K261624 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 56d
Cleared Jul 10, 2026
AI Contouring (VA10A)
K261306 · QKB
Varian Medical Systems
Radiology · 81d
Cleared Jul 10, 2026
Flowflex Plus RSV + Flu A/B + COVID Rapid Test
K261212 · SCA
ACON Laboratories, Inc.
Microbiology · 87d
Cleared Jul 10, 2026
Electric Wheelchair (DY611A-2, DY612A-1)
K261149 · ITI
Zhejiang Lumbre Electric Appliance...
Physical Medicine · 93d
Cleared Jul 10, 2026
ClearSafe Closed System
K261041 · FOZ
MedSource Labs, LLC
General Hospital · 101d
Cleared Jul 10, 2026
POSEIDON ST
K261031 · MQP
Signus Medinzintechnik GmbH
Orthopedic · 102d
Cleared Jul 10, 2026
Cochlear™ Osia® 3(I) Sound Processor
K260902 · PFO
Cochlear Americas
Ear, Nose, Throat · 114d