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

1,198 results for "regulatory technology services, llc"
457–480 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 05, 2016
SonoSite SII Ultrasound System
K160734 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 19d
Cleared Apr 04, 2016
Acclarix LX8 Diagnostic Ultrasound System
K160790 · IYN
Edan Instruments, Inc.
Radiology · 13d
Cleared Mar 22, 2016
cryoFORM cryoICE cryoablation probe
K152337 · GEH
AtriCure, Inc.
General & Plastic Surgery · 216d
Cleared Mar 21, 2016
SpeqT
K160420 · IYO
Signostics Limited
Radiology · 34d
Cleared Mar 17, 2016
OVENT
K160234 · LRK
Oventus Manufacturing Pty, Ltd.
Dental · 45d
Cleared Mar 16, 2016
FUJIFILM FC1 Ultrasound System
K160406 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 29d
Cleared Mar 11, 2016
Surefire Infusion System
K160662 · DQO
Surefire Medical, Inc.
Cardiovascular · 2d
Cleared Mar 01, 2016
Wrist 3
K160185 · LNH
Aspect Imaging, Ltd.
Radiology · 34d
Cleared Feb 19, 2016
I4 (Integrated Intelligent Imaging Informatics) system
K160315 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 14d
Cleared Feb 12, 2016
Spirit Hair Removal laser Family
K153718 · GEX
Active Optical Systems , Ltd.
General & Plastic Surgery · 46d
Cleared Feb 12, 2016
WHILL Model M
K153543 · ITI
Whill, Inc.
Physical Medicine · 63d
Cleared Feb 02, 2016
WS80A Diagnostic Ultrasound System
K153529 · IYN
Samsung Medison Co., Ltd.
Radiology · 55d
Cleared Jan 20, 2016
SonoSite Edge II Ultrasound System
K153626 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 33d
Cleared Jan 15, 2016
HEALTHMYNE
K153289 · LLZ
Healthmyne, Inc.
Radiology · 63d
Cleared Dec 21, 2015
HM70A Diagnostic Ultrasound System
K153408 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
Cleared Dec 16, 2015
ClearVue850 Diagnostic Ultrasound System
K153480 · IYN
Philips Health Care
Radiology · 14d
Cleared Dec 14, 2015
ViSi Mobile Monitoring System
K152341 · MWI
Sotera Wireless, Inc.
Cardiovascular · 117d
Cleared Dec 14, 2015
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate...
K152202 · DQY
Tni Manufacturing, Inc.
Cardiovascular · 130d
Cleared Nov 19, 2015
BladderScan Prime System
K153101 · IYO
Verathon Incorporated
Radiology · 24d
Cleared Nov 18, 2015
Philips IntelliSpace Cardiovascular
K153022 · LLZ
Philips Medical Systems Nethrlands BV
Radiology · 34d
Cleared Nov 16, 2015
UroNav (Version 2.0)
K153073 · LLZ
Invivo Corporation
Radiology · 25d
Cleared Nov 13, 2015
Sirius Max Dental Diode Curing Light
K152936 · EBZ
National Dental, Inc.
Dental · 39d
Cleared Nov 12, 2015
FUJIFILM SonoSite iViz Ultrasound System
K152983 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d
Cleared Nov 02, 2015
HS70A Diagnostic Ultrasound System
K152962 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d