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"
385–408 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 03, 2017
Arisure Closed Vial Adapter
K172884 · LHI
Yukon Medical
General Hospital · 12d
Cleared Sep 29, 2017
Arisure Dry Spike
K172631 · LHI
Yukon Medical
General Hospital · 28d
Cleared Sep 27, 2017
Peerbridge Cor(TM) System
K171936 · DSH
Peerbridge Health, Inc.
Cardiovascular · 91d
Cleared Sep 17, 2017
BD Cathena Safety IV Catheter
K172506 · FOZ
Becton, Dickinson and Company
General Hospital · 30d
Cleared Sep 15, 2017
BladderScan Prime PLUS System
K172356 · IYO
Verathon Incorporated
Radiology · 43d
Cleared Sep 14, 2017
3D Echo
K172513 · LLZ
Jointvue, LLC
Radiology · 24d
Cleared Sep 14, 2017
Clarius Ultrasound System
K172385 · IYN
Clarius Mobile Health Corp.
Radiology · 37d
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 16, 2017
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
K172162 · IYN
Siemens Healthcare
Radiology · 29d
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 31, 2017
Scanmate Flex
K171301 · IYO
Dgh Technology, Inc.
Radiology · 89d
Cleared Jul 19, 2017
MaxZero Extension Sets with Needless Connector
K171957 · FPA
Carefusion 303, Inc.
General Hospital · 20d
Cleared Jul 12, 2017
Acuson SC2000 Diagnostic Ultrasound System
K171766 · IYO
Siemens Medi Cal Solutions, Inc.
Radiology · 28d
Cleared Jun 23, 2017
HyPHo Laser System
K163449 · GEX
Hyper Photonics Srl
General & Plastic Surgery · 197d
Cleared Jun 22, 2017
VITRUVIAN INFILTRATION PUMP
K170629 · QPB
Black & Black Surgical, Inc.
General & Plastic Surgery · 112d
Cleared Jun 12, 2017
SonoSite X-Porte Ultrasound System
K171437 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 27d
Cleared Jun 07, 2017
SmartTarget
K170250 · LLZ
Smarttarget, Ltd.
Radiology · 131d
Cleared Jun 02, 2017
Closed Male Luer
K171101 · FPA
Yukon Medical
General Hospital · 50d
Cleared May 30, 2017
QLAB Advanced Quantification Software
K171314 · LLZ
Philips Health Care
Radiology · 26d
Cleared May 23, 2017
Plasma Edge System
K163090 · FAS
Chirurgie Innovation
Gastroenterology & Urology · 200d
Cleared May 18, 2017
LaparoLight Veress Needle
K171139 · HIF
Buffalo Filter, LLC
Obstetrics & Gynecology · 30d
Cleared May 17, 2017
Surefire Precision Infusion System
K171355 · DQO
Surefire Medical, Inc.
Cardiovascular · 8d