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"
361–384 of 750
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 04, 2017
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound...
K172607 · IYN
Philips Health Care
Radiology · 35d
Cleared Sep 17, 2017
BD Cathena Safety IV Catheter
K172506 · FOZ
Becton, Dickinson and Company
General Hospital · 30d
Cleared Sep 14, 2017
Bard Mission Disposable Core Biopsy Instrument
K171953 · KNW
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 77d
Cleared Aug 17, 2017
BD Intima II PLUS Closed IV Catheter System
K172204 · FOZ
Becton, Dickinson and Company
General Hospital · 27d
Cleared Aug 15, 2017
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic...
K172374 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 8d
Cleared Aug 08, 2017
HS40 Diagnostic Ultrasound System
K172129 · IYN
Samsung Medison Co., Ltd.
Radiology · 25d
Cleared Jul 12, 2017
Acuson SC2000 Diagnostic Ultrasound System
K171766 · IYO
Siemens Medi Cal Solutions, Inc.
Radiology · 28d
Cleared Jun 12, 2017
SonoSite X-Porte Ultrasound System
K171437 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 27d
Cleared May 30, 2017
QLAB Advanced Quantification Software
K171314 · LLZ
Philips Health Care
Radiology · 26d
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 10, 2017
BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless...
K170336 · FOZ
Becton, Dickinson and Company
General Hospital · 36d
Cleared Feb 28, 2017
BD Nexiva Diffusics Closed IV Catheter System
K170283 · FOZ
Becton, Dickinson and Company
General Hospital · 29d
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 04, 2017
ACUSON P500 Ultrasound System
K163396 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 30d
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
Cleared Oct 03, 2016
Lumify Ultrasound System
K162549 · IYN
Philips Health Care
Radiology · 20d
Cleared Sep 28, 2016
Acuson Freestyle Ultrasound System
K162417 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 29d
Cleared Sep 14, 2016
CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System
K162329 · IYN
Philips Health Care
Radiology · 26d
Cleared Sep 14, 2016
dS FootAnkle I6CH 1.5T Coil
K162177 · MOS
Invivo Corporation
Radiology · 41d