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"
745–768 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 03, 2011
ATRICURE CRYO MODULE SYSTEM
K112072 · GEH
AtriCure, Inc.
General & Plastic Surgery · 14d
Cleared Aug 02, 2011
ANCHORWIRE GUIDEWIRE
K111288 · DQX
Lake Region Medical
Cardiovascular · 88d
Cleared Jul 28, 2011
VITREAVIEW SOFTWARE 6.1
K111892 · LLZ
Vital Images, Inc.
Radiology · 23d
Cleared Jul 28, 2011
INTELLISPACE PACS 4.X
K111804 · LLZ
Philips Healthcare Informatics, Inc.
Radiology · 31d
Cleared Jul 13, 2011
VACCESS PTA DILATATION CATHETER
K111850 · DQY
C.R. Bard, Inc.
Cardiovascular · 14d
Cleared Jun 30, 2011
ACUSON
K111674 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jun 30, 2011
SIROCCO THERMAL REGULATING SYSTEM
K102856 · DWJ
Galmaz Biotech S.L.
Cardiovascular · 274d
Cleared Jun 24, 2011
IMPAX VOLUME VIEWING
K111638 · LLZ
Agfa Healthcare N.V.
Radiology · 11d
Cleared Jun 24, 2011
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
K111513 · IYN
Philips Ultrasound, Inc.
Radiology · 23d
Cleared Jun 21, 2011
QLAB 8.1 QUANTIFICATION SOFTWARE
K110414 · LLZ
Philips Ultrasound, Inc.
Radiology · 127d
Cleared Jun 13, 2011
MAX PULSE SYSTEM
K110374 · JOM
Medicore Co., Ltd.
Cardiovascular · 124d
Cleared Jun 03, 2011
BILLY BOY MALE LATEX CONDOM
K111093 · HIS
Mapa GmbH
Obstetrics & Gynecology · 45d
Cleared Jun 03, 2011
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
K110645 · DSB
Sonosite,Inc.
Cardiovascular · 91d
Cleared Jun 02, 2011
MYLABGOLD
K110688 · IYO
Esaote
Radiology · 83d
Cleared May 26, 2011
ATRICURE CRYO MODULE
K111042 · GEH
AtriCure, Inc.
General & Plastic Surgery · 41d
Cleared May 24, 2011
AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE
K102534 · LLZ
Aze, Ltd.
Radiology · 263d
Cleared May 16, 2011
FUJINON ULTRASONIC PROCESSOR
K111243 · FDS
Fujinon, Inc.
Radiology · 13d
Cleared May 13, 2011
VR MEDICAL ENTERAL ORAL SYRINGE
K110853 · FPD
Vr Medical
Gastroenterology & Urology · 46d
Cleared May 13, 2011
TERUMO SUPPORT CATHETER
K110540 · DQY
Terumo Medical Corp.
Cardiovascular · 77d
Cleared May 12, 2011
SIMPLEABI
K110628 · JAF
Newman Medical
Radiology · 70d
Cleared May 06, 2011
EUNITY
K111164 · LLZ
Client Outlook, Inc.
Radiology · 10d
Cleared May 03, 2011
ICON ADULT MANUAL
K110985 · IOR
Icon Wheelchairs, Inc.
Physical Medicine · 25d
Cleared Apr 15, 2011
REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
K102418 · DQY
Reverse Medical Corporation
Cardiovascular · 233d
Cleared Apr 08, 2011
UF-760AG
K110920 · ITX
Fukuda Denshi Co., Ltd.
Radiology · 7d