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
21193–21216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2019
Comet II Pressure Guidewire
K193279 · DXO
Boston Scientific Corporation
Cardiovascular · 26d
Cleared Dec 21, 2019
Acetabular Bone Screws (for MobileLink Acetabular Cup System)
K192559 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 95d
Cleared Dec 21, 2019
Spinalytics
K192629 · LXM
Optima Health Solutions International...
Neurology · 89d
Cleared Dec 20, 2019
IceSense 3, ProSense, MultiSense
K183213 · GEH
IceCure Medical , Ltd.
General & Plastic Surgery · 396d
Cleared Dec 20, 2019
Carescape One
K190008 · MHX
Ge Healthcare
Cardiovascular · 352d
Cleared Dec 20, 2019
Non-Sterile Zirconia Block
K190112 · EIH
Fine Advanced Compound Co., Ltd.
Dental · 331d
Cleared Dec 20, 2019
Bengal Stackable Cage System
K190284 · PLR
Medos International SARL
Orthopedic · 312d
Cleared Dec 20, 2019
NanoOrtho NanoKnee® System
K190633 · HRY
Nanoortho, LLC
Orthopedic · 283d
Cleared Dec 20, 2019
IODOSORB
K190730 · FRO
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 274d
Cleared Dec 20, 2019
IODOFLEX
K190756 · FRO
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 270d
Cleared Dec 20, 2019
PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI...
K190805 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 266d
Cleared Dec 20, 2019
xvision Spine system (XVS)
K190929 · SBF
Augmedics, Ltd.
Orthopedic · 255d
Cleared Dec 20, 2019
APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC...
K191234 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 226d
Cleared Dec 20, 2019
ACTIVE® Free Testosterone RIA
K191350 · CDZ
Immunotech S.R.O.
Chemistry · 214d
Cleared Dec 20, 2019
Pulse Oximeter
K191403 · DQA
Nonin Medical, Inc.
Anesthesiology · 210d
Cleared Dec 20, 2019
Paragonix SherpaPak Pancreas Transport System
K191440 · KDN
Paragonix Technologies
Gastroenterology & Urology · 204d
Cleared Dec 20, 2019
QLAB Advanced Quantification Software
K191647 · QIH
Philips Health Care
Radiology · 183d
Cleared Dec 20, 2019
Unscented W long plastic and cardboard applicator tampons
K191666 · HEB
Ontex Bvba
Obstetrics & Gynecology · 182d
Cleared Dec 20, 2019
Clear-Aligners
K191823 · NXC
Cdb Corporation
Dental · 165d
Cleared Dec 20, 2019
Ceramill A-Splint
K191836 · MQC
Amann Girrbach AG
Dental · 164d
Cleared Dec 20, 2019
DRX-Evolution with Carestream Digital Tomosynthesis
K191879 · KPR
Carestream Health, Inc.
Radiology · 158d
Cleared Dec 20, 2019
Unyvero LRT BAL Application
K191967 · QBH
Curetis GmbH
Microbiology · 150d
Cleared Dec 20, 2019
WEREWOLF COBLATION System, COBLATION HALO Wand
K192027 · GEI
ArthroCare Corporation
General & Plastic Surgery · 144d
Cleared Dec 20, 2019
AVIEW Modeler
K192040 · LLZ
Coreline Soft Co., Ltd.
Radiology · 142d