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
27865–27888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2017
Aquarius 8600 1417WC
K171175 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 167d
Cleared Oct 05, 2017
R2P Destination Slender Guiding Sheath
K171491 · DYB
Terumo Medical Corporation
Cardiovascular · 136d
Cleared Oct 05, 2017
Reprocessed CristaCath Diagnostic Electrophysiology Catheter
K171503 · NLH
Innovative Health, LLC
Cardiovascular · 135d
Cleared Oct 05, 2017
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
K171689 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Oct 05, 2017
LinkQuest Diagnostic Ultrasound System model SQ860
K172059 · IYN
Linkquest, Inc.
Radiology · 90d
Cleared Oct 05, 2017
PROLENE Soft Polypropylene Mesh
K172089 · FTL
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Oct 05, 2017
Reprocessed Covidien Trocar
K172093 · NLM
Renovo, Inc.
Gastroenterology & Urology · 86d
Cleared Oct 05, 2017
Shoocin Introducer Kit
K172099 · DYB
Lepu Medical Technology (Beijing)...
Cardiovascular · 86d
Cleared Oct 05, 2017
Biomet Bone Cement R
K172408 · LOD
Biomet, Inc.
Orthopedic · 57d
Cleared Oct 05, 2017
iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
K172558 · KNW
Stryker Corporation
Gastroenterology & Urology · 42d
Cleared Oct 05, 2017
SyncVision System
K172574 · OWB
Volcano Corporation
Radiology · 38d
Cleared Oct 05, 2017
MagVita TMS Therapy w/MagPro R20
K172667 · OBP
Tonica Elektronik A/S
Neurology · 30d
Cleared Oct 05, 2017
Vitrea Advanced Visualization, Version 7.6
K172855 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared Oct 04, 2017
ri-former Predictive Thermometer
K171182 · FLL
Rudolf Riester GmbH
General Hospital · 163d
Cleared Oct 04, 2017
EMPOWR Porous Knee System
K171991 · MBH
Encore Medical, L.P.
Orthopedic · 93d
Cleared Oct 04, 2017
Reprocessed Shavers/Burs
K172092 · HRX
Renovo, Inc.
Orthopedic · 85d
Cleared Oct 04, 2017
Philips IntelliSite Pathology Solution
K172174 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 77d
Cleared Oct 04, 2017
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
K172289 · FAD
Q Urological Corporation
Gastroenterology & Urology · 65d
Cleared Oct 04, 2017
CRE RX Biliary Balloon Dilatation Catheter
K172520 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Oct 04, 2017
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound...
K172607 · IYN
Philips Health Care
Radiology · 35d
Cleared Oct 04, 2017
HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile...
K172671 · GEI
Conmed Corporation
General & Plastic Surgery · 29d
Cleared Oct 04, 2017
Ultrasonic Generator
K172691 · LFL
Olympus Medical Systems Corp.
General & Plastic Surgery · 28d
Cleared Oct 03, 2017
Force Fiber Fusion Suture
K172016 · GAT
Teleflex Medical Incorporated
General & Plastic Surgery · 92d
Cleared Oct 03, 2017
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022 · JXG
Codman & Shurtleff, Inc.
Neurology · 90d