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

681 results for "regulatory technology services, llc"
481–504 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 27, 2011
DX-D 600
K112670 · KPR
Agfa Healthcare N.V.
Radiology · 43d
Cleared Oct 12, 2011
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K112646 · IYN
Samsung Medison Co., Ltd.
Radiology · 30d
Cleared Aug 29, 2011
ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
K112339 · IYN
Samsung Medison Co., Ltd.
Radiology · 14d
Cleared Aug 26, 2011
COMFORTGLIDE INTERMITENT CATHETER
K112137 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 31d
Cleared Aug 25, 2011
YOULASER CO2 LASER SYSTEM
K111592 · GEX
Quanta System Spa
General & Plastic Surgery · 79d
Cleared Aug 17, 2011
CROSSER RECANALIZATION SYSTEM
K112308 · PDU
C.R. Bard, Inc.
Cardiovascular · 6d
Cleared Aug 05, 2011
IMPAX NEXT GENERATION
K111945 · LLZ
Agfa Healthcare N.V.
Radiology · 28d
Cleared Aug 03, 2011
ATRICURE CRYO MODULE SYSTEM
K112072 · GEH
AtriCure, Inc.
General & Plastic Surgery · 14d
Cleared Jul 28, 2011
VITREAVIEW SOFTWARE 6.1
K111892 · LLZ
Vital Images, Inc.
Radiology · 23d
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 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 May 26, 2011
ATRICURE CRYO MODULE
K111042 · GEH
AtriCure, Inc.
General & Plastic Surgery · 41d
Cleared May 16, 2011
FUJINON ULTRASONIC PROCESSOR
K111243 · FDS
Fujinon, Inc.
Radiology · 13d
Cleared May 13, 2011
TERUMO SUPPORT CATHETER
K110540 · DQY
Terumo Medical Corp.
Cardiovascular · 77d
Cleared Feb 08, 2011
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
K110202 · ITX
Fujifilm Medical System U.S.A., Inc.
Radiology · 15d
Cleared Feb 02, 2011
FINESS ENDOSCOPE STERILIZATION TRAY
K103213 · KCT
Entellus Medical, Inc.
General Hospital · 93d
Cleared Jan 26, 2011
VANTAGE VIEW SYSTEM
K110085 · DXJ
St Jude Medical
Cardiovascular · 15d
Cleared Jan 25, 2011
Q-STATION
K103815 · LLZ
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Jan 20, 2011
QUANTA SYSTEM DUOLITE
K103539 · GEX
Quanta System Spa
General & Plastic Surgery · 49d
Cleared Jan 05, 2011
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K103618 · MCW
Ev3, Inc.
Cardiovascular · 26d
Cleared Jan 03, 2011
DX-D 100
K103597 · IZL
Agfa Healthcare N.V.
Radiology · 26d