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
19345–19368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 2020
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
K193492 · QDJ
23AndMe, Inc.
Chemistry · 244d
Cleared Aug 17, 2020
EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
K200648 · QEY
Ekos Corporation
Cardiovascular · 158d
Cleared Aug 17, 2020
WallFlex Colonic Stent System with Anchor Lock Delivery System
K201159 · MQR
Boston Scientific Corporation
Gastroenterology & Urology · 109d
Cleared Aug 17, 2020
RadGil2
K201177 · MOT
R3 X-Ray L.L.C
Radiology · 108d
Cleared Aug 17, 2020
3D Auto LAA
K201352 · LLZ
Philips Health Care
Radiology · 88d
Cleared Aug 17, 2020
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR...
K201399 · OWN
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 81d
Cleared Aug 16, 2020
Sirona Dental CAD/CAM System with CEREC Chairside Software
K193408 · NHA
Dentsply Sirona
Dental · 251d
Cleared Aug 14, 2020
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head
K191708 · LPH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 415d
Cleared Aug 14, 2020
Orthocem, Ortho Bite
K192682 · DYH
Dentscare Ltda
Dental · 323d
Cleared Aug 14, 2020
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
K200064 · MQV
SurGenTec, LLC
Orthopedic · 214d
Cleared Aug 14, 2020
LOOP LED Curing Light System
K200775 · EBZ
Garrison Dental Solutions, LLC
Dental · 142d
Cleared Aug 14, 2020
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
K200848 · GZF
Micron Medical Corporation
Neurology · 136d
Cleared CT Aug 14, 2020
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill...
K201010 · EBF
Nobio , Ltd.
Dental · 119d
Cleared Aug 14, 2020
Route 92 Medical 088 Access System
K201518 · QJP
Route 92 Medical
Neurology · 67d
Cleared Aug 14, 2020
TOMTEC-ARENA
K201632 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 59d
Cleared Aug 14, 2020
The AIO Solution 3.0
K202068 · IYE
Orfit Industries NV
Radiology · 18d
Cleared Aug 14, 2020
BracePaste Band and Build LC
K202276 · DYH
American Orthodontics
Dental · 3d
Cleared Aug 13, 2020
StimaWELL 120MTRS
K181645 · GZJ
Pierenkemper GmbH
Neurology · 783d
Cleared Aug 13, 2020
Cuffix
K192611 · BSK
Biovo Technologies , Ltd.
Anesthesiology · 328d
Cleared Aug 13, 2020
AncestryDNA Factor V Leiden Genetic Health Risk Test
K192944 · PTA
Ancestry Genomics, Inc.
Hematology · 300d
Cleared Aug 13, 2020
AncestryDNA Saliva Collection Kit
K192947 · OYJ
Ancestry Genomics, Inc.
Chemistry · 300d
Cleared Aug 13, 2020
Straumann® Retentive System – Novaloc TiN Abutments
K193046 · NHA
Institut Straumann AG
Dental · 286d
Cleared Aug 13, 2020
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
K193429 · JDI
Howmedica Osteonics Corp.
Orthopedic · 247d
Cleared Aug 13, 2020
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream
K200133 · LCX
Safecare Biotech (Hangzhou) Co., Ltd.
Chemistry · 205d