FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

750 results for "Regulatory Technology Services, LLC"
385–408 of 750
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 08, 2016
SonoSite iViz Ultrasound System
K162288 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 24d
Cleared Sep 06, 2016
ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System
K162243 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 27d
Cleared Aug 31, 2016
1.5T and 3.0T 16 CH GE Shoulder Coils
K162001 · MOS
Invivo Corporation
Radiology · 42d
Cleared Aug 29, 2016
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
K161777 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 61d
Cleared Aug 26, 2016
RS80A Diagnostic Ultrasound System
K162094 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Aug 18, 2016
SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System
K162045 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 24d
Cleared Aug 10, 2016
5D Viewer
K161955 · LLZ
Samsung Medison Co., Ltd.
Radiology · 23d
Cleared Jul 28, 2016
ACUSON NX2 Diagnostic Ultrasound Systems
K161787 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jun 03, 2016
Halo One Thin-Walled Guiding Sheath
K161183 · DYB
C.R. Bard, Inc.
Cardiovascular · 37d
Cleared May 13, 2016
SonoSite iViz Ultrasound System
K161119 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 23d
Cleared Apr 19, 2016
Fujifilm Sonosite Vevo MD Imaging System
K160674 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 40d
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 16, 2016
FUJIFILM FC1 Ultrasound System
K160406 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 29d
Cleared Feb 19, 2016
I4 (Integrated Intelligent Imaging Informatics) system
K160315 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 14d
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 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 Nov 16, 2015
UroNav (Version 2.0)
K153073 · LLZ
Invivo Corporation
Radiology · 25d
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
Cleared Oct 21, 2015
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound...
K152763 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 27d