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
793–816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 2026
SedLine Sedation Monitor
K260880 · OLW
Masimo Corporation
Anesthesiology · 115d
Cleared Jul 10, 2026
Sofia Lyme FIA
K254295 · LSR
Ortho-Clinical Diagnostics, Inc....
Microbiology · 191d
Cleared Jul 10, 2026
LungFlow Airway Catheter
K254037 · EOQ
Free Flow Medical, Inc.
Anesthesiology · 206d
Cleared Jul 10, 2026
SmartCT (R3.0 (L10))
K253670 · OWB
Philips Medical Systems B.V.
Radiology · 231d
Cleared Jul 10, 2026
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220)
K253514 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 246d
Cleared Jul 10, 2026
Capenergy C Equipments RF C200 and C400 Drakarian
K253480 · PBX
Capenergy Medical S.L.
General & Plastic Surgery · 269d
Cleared Jul 09, 2026
Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable...
K261988 · NEW
Teleflex Medical, LLC
General & Plastic Surgery · 27d
Cleared Jul 09, 2026
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue...
K261968 · MBI
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jul 09, 2026
SmartGuard Technology
K261962 · QJI
Medtronic Minimed
Chemistry · 28d
Cleared Jul 09, 2026
UbiqVue™ 2AYe Cardiac System (UX2253)
K261569 · DRG
Lifesignals, Inc.
Cardiovascular · 58d
Cleared Jul 09, 2026
Zeta TMS Navigation System
K261471 · QFF
Zeta Surgical, Inc.
Neurology · 66d
Cleared Jul 09, 2026
PINKSLIP Water-Based Personal Lubricant and Moisturizer
K261177 · NUC
PINKSLIP, LLC
Obstetrics & Gynecology · 90d
Cleared Jul 09, 2026
DIA-CEM
K261166 · EMA
DiaDent Group International
Dental · 91d
Cleared Jul 09, 2026
HYDROS Robotic System (HY1000)
K260723 · PZP
Procept Biorobotics
Gastroenterology & Urology · 126d
Cleared Jul 09, 2026
MedSource QuickSafe™ Safety IV Catheter
K260539 · FOZ
MedSource Labs, LLC
General Hospital · 142d
Cleared Jul 09, 2026
LifeLens Physiological Monitor
K260157 · DSH
LifeLens Technologies, Inc.
Cardiovascular · 170d
Cleared Jul 09, 2026
Millipede88 Access Catheter
K253901 · QJP
Perfuze, Ltd.
Neurology · 216d
Cleared Jul 09, 2026
3D-Anywhere
K253899 · LLZ
Provect.AI
Radiology · 216d
Cleared Jul 09, 2026
ScioCardio ECG Analysis Platform
K252978 · DQK
Synergen Technology Labs, LLC
Cardiovascular · 295d
Cleared Jul 08, 2026
Denture Base Resin V2
K262300 · EBI
Formlabs Ohio, Inc.
Dental · 1d
Cleared Jul 08, 2026
Electric Wheelchair
K261396 · ITI
Ningbo Resshidi Medical Devices Co.,...
Physical Medicine · 70d
Cleared Jul 08, 2026
Alians Elbow S
K261191 · HRS
Newclip Technics
Orthopedic · 86d
Cleared Jul 08, 2026
cobas CT/NG for use on the cobas 5800/6800/8800 systems
K260917 · QEP
Roche Molecular Systems, Inc.
Microbiology · 111d
Cleared Jul 08, 2026
Virtual Cone (1.0)
K260750 · MUJ
Varian Medical Systems, Inc.
Radiology · 124d