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"
505–528 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 22, 2010
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K102391 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 121d
Cleared Dec 13, 2010
VASCUTRAK PTA DILATATION CATHETER
K103459 · PNO
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Dec 10, 2010
QUANTA CYBER TM 150W
K102749 · GEX
Quanta System Spa
General & Plastic Surgery · 78d
Cleared Dec 08, 2010
SEEKER CROSSING SUPPORT CATHETER
K103367 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 22d
Cleared Dec 06, 2010
EVERCROSS 0.035 OTW PTA DILATION CATHETER
K103322 · LIT
Ev3, Inc.
Cardiovascular · 24d
Cleared Oct 29, 2010
DX-D 300
K103050 · KPR
Agfa Healthcare N.V.
Radiology · 14d
Cleared Sep 22, 2010
ENSITE VERISMO SEGMENTATION TOOL V.2.0
K101697 · LLZ
St Jude Medical
Radiology · 98d
Cleared Sep 20, 2010
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K102017 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Aug 09, 2010
ALLURA XPER OR TABLE SERIES
K102005 · OWB
Philips Medical Systems North...
Radiology · 25d
Cleared Aug 06, 2010
HEADWAY 17 ADVANCED MICROCATHETER
K101542 · DQY
MicroVention, Inc.
Cardiovascular · 64d
Cleared Jul 22, 2010
QUANTA DIODE LASER SYSTEM
K100558 · GEX
Quanta System Spa
General & Plastic Surgery · 143d
Cleared Jul 21, 2010
GLIDESHEATH
K102008 · DYB
Terumo Medical Corp.
Cardiovascular · 5d
Cleared Jun 03, 2010
BD INTIMA II CLOSED IV CATHETER
K100775 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 77d
Cleared May 14, 2010
MRI PATIENT POSITIONING DEVICES
K093738 · LNH
Medtec, Inc.
Radiology · 161d
Cleared Apr 28, 2010
ROLL-X GUIDEWIRE
K100710 · DQX
St Jude Medical
Cardiovascular · 47d
Cleared Mar 17, 2010
MODEL VISULAS 532S LASER WITH THE VITE OPTION
K100035 · GEX
Carl Zeiss Meditec, AG
General & Plastic Surgery · 70d
Cleared Mar 03, 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Feb 26, 2010
TRAILRUNNER GUIDEWIRES
K092965 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 154d
Cleared Feb 25, 2010
ENSITE VELOCITY SYSTEM V1.3
K093942 · DQK
St Jude Medical
Cardiovascular · 65d
Cleared Feb 01, 2010
IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
K093563 · IYN
Philips Ultrasound, Inc.
Radiology · 75d
Cleared Jan 28, 2010
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
K100067 · ITX
Toshiba America Medical Systems, In.C
Radiology · 17d
Cleared Dec 15, 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
K093583 · DQK
St Jude Medical
Cardiovascular · 26d
Cleared Dec 04, 2009
VIAMO SSA-640A VERSION 1.2
K093171 · IYN
Toshiba America Medical Systems, In.C
Radiology · 57d
Cleared Dec 01, 2009
ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
K093531 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 15d