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"
457–480 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 13, 2012
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
K122535 · EOQ
Fujifilm Medical System U.S.A., Inc.
Ear, Nose, Throat · 115d
Cleared Dec 05, 2012
ACUSON
K123622 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared Nov 20, 2012
3M TRUE DEFINITION SCANNER
K122467 · NOF
3M Company
Dental · 99d
Cleared Nov 02, 2012
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
K122938 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 39d
Cleared Oct 26, 2012
ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
K123001 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Oct 22, 2012
ATLAS GOLD PTA DILATATION CATHETER
K122984 · LIT
C.R. Bard, Inc.
Cardiovascular · 26d
Cleared Sep 28, 2012
ACUSON
K122825 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Sep 13, 2012
VIAMO SSA-640A V4.0
K122491 · IYN
Toshibamedical Systems Corporation
Radiology · 29d
Cleared Sep 12, 2012
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE...
K122569 · EBF
3M Company
Dental · 20d
Cleared Sep 05, 2012
UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM
K122583 · IYN
Samsung Medison Co., Ltd.
Radiology · 12d
Cleared Aug 16, 2012
DX-D IMAGING PACKAGE
K121095 · MQB
Agfa Healthcare N.V.
Radiology · 127d
Cleared Aug 13, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
K120446 · FDS
Fujinon, Inc.
Radiology · 181d
Cleared Jul 20, 2012
CR 10-X DIGITIZER
K121948 · MQB
Agfa Healthcare N.V.
Radiology · 17d
Cleared Jul 10, 2012
V5MS TRANSDUCER
K121807 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Jun 22, 2012
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND...
K121699 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Jun 06, 2012
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
K121507 · GEH
AtriCure, Inc.
General & Plastic Surgery · 16d
Cleared Jun 04, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
K121035 · EOQ
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared May 15, 2012
QLAB WITH FHN AND VPQ PLUG-IN
K121223 · LLZ
Philips Ultrasound, Inc.
Radiology · 22d
Cleared Apr 19, 2012
ATLAS PTA BALLOON DILATATION CATHETER
K120971 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 17d
Cleared Apr 19, 2012
WHOLEY GUIDE WIRE SYSTEM
K120863 · DQX
Covidien, LLC
Cardiovascular · 28d
Cleared Apr 19, 2012
RIVAL PTA DILATATION CATHETER
K120722 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 41d
Cleared Mar 15, 2012
CONQUEST 40 PTA DILATATION CATHETER
K120660 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 10d
Cleared Mar 15, 2012
CONCENTRIC BALLOON GUIDE CATHETER
K112404 · DQY
Concentric Medical, Inc.
Cardiovascular · 206d
Cleared Dec 29, 2011
MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM
K113381 · IYN
Samsung Medison Co., Ltd.
Radiology · 43d