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"
409–432 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 09, 2017
Guider Catheter Introducer
K171081 · DYB
Rhythm Xience, Inc. (Rxi)
Cardiovascular · 28d
Cleared May 04, 2017
Nucleus Image Management System
K171130 · LLZ
Nucleushealth, LLC
Radiology · 17d
Cleared May 02, 2017
AXIS Image Management System
K171098 · NFJ
Sonomed, Inc.
Ophthalmic · 19d
Cleared Apr 18, 2017
Plato MICROCATH 27B Microcatheter
K170406 · DQO
Scientia Vascular, LLC
Cardiovascular · 67d
Cleared Apr 04, 2017
Acuson SC2000 Diagnostic Ultrasound System
K170315 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 62d
Cleared Mar 28, 2017
HS50 / HS60 Diagnostic Ultrasound System
K170493 · IYN
Samsung Medison Co., Ltd.
Radiology · 39d
Cleared Mar 22, 2017
ThermoShield HME Filter
K163300 · CAH
Flexicare Medical Limited.
General Hospital · 120d
Cleared Mar 10, 2017
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless...
K170336 · FOZ
Becton, Dickinson and Company
General Hospital · 36d
Cleared Mar 03, 2017
True 3D Viewer Software
K170167 · LLZ
Echopixel, Inc.
Radiology · 43d
Cleared Feb 28, 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283 · FOZ
Becton, Dickinson and Company
General Hospital · 29d
Cleared Feb 27, 2017
Flextra Steerable Introducer
K170373 · DYB
Rhythm Xience, Inc. (Rxi)
Cardiovascular · 20d
Cleared Feb 24, 2017
Vesco Medical NRFit Tip Syringes
K170218 · FMF
Vesco Medical, LLC
General Hospital · 30d
Cleared Feb 22, 2017
HS70A Diagnostic Ultrasound System
K163691 · IYN
Samsung Medison Co., Ltd.
Radiology · 56d
Cleared Feb 16, 2017
ClotTriever Thrombectomy System
K163549 · QEW
Inari Medical, Inc.
Cardiovascular · 62d
Cleared Feb 06, 2017
3M Protemp Cement Temporary Dental Cement
K170330 · EMA
3M Company
Dental · 4d
Cleared Jan 27, 2017
3M Clear Tray Aligner
K163689 · NXC
3M Unitek Corporation
Dental · 30d
Cleared Jan 12, 2017
ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems
K163635 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 21d
Cleared Jan 04, 2017
ACUSON P500 Ultrasound System
K163396 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Dec 02, 2016
ExactVu High Resolution Micro-Ultrasound System
K162972 · IYO
Exact Imaging
Radiology · 38d
Cleared Dec 01, 2016
CyMedica e-vive™ System
K163067 · IPF
Cymedica Orthopedics, Inc.
Physical Medicine · 29d
Cleared Nov 30, 2016
Clarius Ultrasound System
K163138 · IYN
Clarius Mobile Health Corp.
Radiology · 21d
Cleared Nov 30, 2016
Solution Set for Epidural Use
K161323 · FPA
Baxter Healthcare Corporation
General Hospital · 203d
Cleared Nov 28, 2016
Filtek One Bulk Fill Restorative
K163207 · EBF
3M Company
Dental · 13d
Cleared Nov 16, 2016
Xperius Ultrasound System
K163020 · IYN
Philips Health Care
Radiology · 16d