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
20449–20472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 2020
Diapaste
K190091 · KIF
DiaDent Group International
Dental · 434d
Cleared Mar 27, 2020
PregSense
K191401 · LQK
Nuvo- Group , Ltd.
Obstetrics & Gynecology · 308d
Cleared Mar 27, 2020
Single Use Grasping Forceps
K191900 · OCZ
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 255d
Cleared Mar 27, 2020
BiWaze Cough
K191912 · NHJ
Abmrc, LLC
Anesthesiology · 254d
Cleared Mar 27, 2020
JJ Series Container System
K192056 · KCT
Aesculap, Inc.
General Hospital · 239d
Cleared Mar 27, 2020
RAPIDPoint 500e Blood Gas System
K192240 · CHL
Siemens Healthcare Diagnostics, Inc.
Chemistry · 221d
Cleared Mar 27, 2020
TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable...
K192389 · FTL
Medtronic, Inc.
General & Plastic Surgery · 206d
Cleared Mar 27, 2020
HBP6 Settable, Resorbable Hemostatic Bone Paste
K193052 · MTJ
Orthocon, Inc.
General & Plastic Surgery · 147d
Cleared Mar 27, 2020
uMR Omega
K193200 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared Mar 27, 2020
SkyPulse
K193656 · GEX
Fotona D.O.O.
General & Plastic Surgery · 88d
Cleared Mar 27, 2020
Silhouette Instalift
K200140 · GAM
Silhouette Lift, Inc.
General & Plastic Surgery · 66d
Cleared Mar 27, 2020
GrandioSO Light Flow
K200294 · EBF
Voco GmbH
Dental · 51d
Cleared Mar 27, 2020
StimRouter Neuromodulation System
K200482 · GZF
Bioness, Inc.
Neurology · 29d
Cleared Mar 27, 2020
CUBEScan BioCon-1100
K200548 · IYO
Mcube Technology Co., Ltd.
Radiology · 24d
Cleared Mar 26, 2020
Konan Specular Microscope XVII
K191558 · NQE
Konan Medical, Inc.
Ophthalmic · 288d
Cleared CT Mar 26, 2020
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
K191749 · OWT
Novus Scientific AB
General & Plastic Surgery · 269d
Cleared Mar 26, 2020
gammaCore Sapphire
K191830 · PKR
Electrocore, Inc.
Neurology · 261d
Cleared Mar 26, 2020
Propeller Sensor for Symbicort
K192724 · CAF
Reciprocal Labs Corporation
Anesthesiology · 181d
Cleared Mar 26, 2020
BodyGuardian Remote Monitoring System
K192732 · DSI
Preventice Technologies, Inc.
Cardiovascular · 181d
Cleared Mar 26, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide...
K192886 · DQX
Volcano Corporation
Cardiovascular · 168d
Cleared Mar 26, 2020
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
K192951 · GEX
Ellipse A/S
General & Plastic Surgery · 157d
Cleared Mar 26, 2020
Aina HbA1c Monitoring System 2
K192987 · LCP
Jana Care, Inc.
Chemistry · 153d
Cleared Mar 26, 2020
Tina-quant Hemoglobin A1cDx Gen.3
K193053 · PDJ
Roche Diagnostics Operations (Rdo)
Chemistry · 146d
Cleared Mar 26, 2020
Bonecam Suture Anchor
K193108 · MBI
Valeris Medical, Inc.
Orthopedic · 139d