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
19753–19776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2020
DuoHex CH Cannulated Hammertoe System
K200840 · HWC
Nextremity Solutions, Inc.
Orthopedic · 87d
Cleared Jun 26, 2020
ChartCheck
K201119 · IYE
Radformation, Inc.
Radiology · 60d
Cleared Jun 26, 2020
Ion Endoluminal System
K201146 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 58d
Cleared Jun 26, 2020
EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software...
K201148 · DQK
Abbott Medical
Cardiovascular · 58d
Cleared Jun 26, 2020
Venus Viva MD Device
K201164 · GEI
Venus Concept USA, Inc.
General & Plastic Surgery · 56d
Cleared Jun 26, 2020
EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System
K201181 · DQK
Abbott Medical
Cardiovascular · 57d
Cleared Jun 26, 2020
DRX-Compass
K201373 · KPR
Carestream Health, Inc.
Radiology · 31d
Cleared Jun 25, 2020
Yumizen C1200 CRP
K192028 · DCK
HORIBA ABX SAS
Immunology · 335d
Cleared Jun 25, 2020
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants
K192221 · DZE
Implant Direct Sybron Manufacturing, LLC
Dental · 315d
Cleared Jun 25, 2020
Blood Pressure Monitor
K193348 · DXN
Shenzhen Viatom Technology Co., Ltd.
Cardiovascular · 205d
Cleared Jun 25, 2020
DIA-ROOT BIO Sealer
K200175 · KIF
DiaDent Group International
Dental · 154d
Cleared Jun 25, 2020
IlluminOss Bone Stabilization System
K200295 · QAD
Illuminoss Medical, Inc.
Orthopedic · 141d
Cleared Jun 25, 2020
Blood Pressure Monitor
K200437 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 122d
Cleared Jun 25, 2020
Bendit2.7 Steerable Microcatheter
K200582 · KRA
Bend IT Technologies, Ltd.
Cardiovascular · 111d
Cleared Jun 25, 2020
FiteBac Antimicrobial Cavity Cleanser
K200614 · LBH
Largent Health, LLC
Dental · 108d
Cleared Jun 25, 2020
VitriGuard
K200815 · MQK
Origio A/S
Obstetrics & Gynecology · 87d
Cleared Jun 25, 2020
Lever Action Plate System
K200834 · HRS
Mcginley Orthpaedic Innovations, LLC
Orthopedic · 87d
Cleared Jun 25, 2020
Rotium Bioresorbable Wick
K201414 · MAI
Nanofiber Solutions, LLC
Orthopedic · 27d
Cleared Jun 24, 2020
The Simple Locking Intramedullary (Slim) System
K192710 · HSB
Pega Medical, Inc.
Orthopedic · 271d
Cleared Jun 24, 2020
Nd: YAG Laser Therapy Systems
K193477 · GEX
Beijing Kes Biology Technology Co., Ltd.
General & Plastic Surgery · 191d
Cleared Jun 24, 2020
The C100 Contactless Breathing Monitor
K200445 · BZQ
Circadia Technologies, Ltd.
Anesthesiology · 121d
Cleared Jun 24, 2020
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
K200495 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 117d
Cleared Jun 24, 2020
ControlRad Trace Model 9
K200663 · OWB
Controlrad, Inc.
Radiology · 103d
Cleared Jun 24, 2020
CINA
K200855 · QAS
Avicenna.Ai
Radiology · 85d