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
20113–20136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 2020
HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor
K200146 · GEI
Covidien, LLC
General & Plastic Surgery · 106d
Cleared May 07, 2020
LOSPA II Knee System (EXULT Knee Replacement System)
K200395 · JWH
Corentec Co., Ltd.
Orthopedic · 79d
Cleared May 07, 2020
Catalyst+, Catalyst+ HD
K200435 · IYE
C-Rad Positioning AB
Radiology · 73d
Cleared May 07, 2020
ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
K200512 · JWY
Biom?rieux SA
Microbiology · 66d
Cleared May 07, 2020
AMF Revision TT Cones
K200653 · JWH
Lima Corporate S.P.A.
Orthopedic · 56d
Cleared May 07, 2020
HS70A Diagnostic Ultrasound System
K200699 · IYN
Samsung Medison Co., Ltd.
Radiology · 51d
Cleared May 07, 2020
Icare HOME Tonometer
K200966 · HKY
Icare Finland OY
Ophthalmic · 27d
Cleared May 06, 2020
Aerodentis System
K192069 · NXC
Dror Orthodesign
Dental · 279d
Cleared May 06, 2020
MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F...
K192283 · DRE
Medron, LLC
Cardiovascular · 258d
Cleared May 06, 2020
LIAISON® Folate
K192586 · CGN
DiaSorin, Inc.
Chemistry · 230d
Cleared May 06, 2020
RFID Localization System
K193189 · NEU
Health Beacons, Inc.
General & Plastic Surgery · 169d
Cleared May 06, 2020
XO Cross Support Catheter
K193420 · DQY
Transit Scientific
Cardiovascular · 149d
Cleared May 06, 2020
CharmFil
K193496 · EBF
Dentkist, Inc.
Dental · 141d
Cleared May 06, 2020
Accuvue+
K201058 · MQB
Radmedix, LLC
Radiology · 15d
Cleared May 05, 2020
AA temp temporary restoration 3D printing photoreactive resin
K191590 · EBG
Enlighten Materials Co., Ltd.
Dental · 326d
Cleared May 05, 2020
uMR 780
K193176 · LNH
Shanghai United Imaging Healthcare...
Radiology · 169d
Cleared May 05, 2020
AVIEW LCS
K193220 · LLZ
Coreline Soft Co., Ltd.
Radiology · 166d
Cleared May 05, 2020
InMode System with vTone Applicator
K200293 · KPI
Inmode , Ltd.
Gastroenterology & Urology · 90d
Cleared May 05, 2020
Ziostation2
K200315 · LLZ
Ziosoft, Inc.
Radiology · 88d
Cleared May 05, 2020
ZeeroMED View
K200546 · LLZ
O3 Enterprise Srl
Radiology · 63d
Cleared May 05, 2020
Balteum™ Lumbar Plate System
K200846 · KWQ
Huvexel Co. , Ltd.
Orthopedic · 35d
Cleared May 05, 2020
Healix Compression Screw System
K200914 · HWC
Nvision Biomedical Technologies, Inc.
Orthopedic · 29d
Cleared May 05, 2020
Syntec Non-Sterile Steinmann Pins System
K200933 · JDW
Syntec Scientific Corporation
Orthopedic · 28d
Cleared May 05, 2020
Lascod Impression Materials
K201184 · ELW
Lascod Spa
Dental · 4d