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"
673–696 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 02, 2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K122133 · MWI
Airstrip Technologies, LP
Cardiovascular · 76d
Cleared Sep 28, 2012
ACUSON
K122825 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Sep 21, 2012
NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
K121773 · GXI
Biomerics
Neurology · 95d
Cleared Sep 21, 2012
TROOPER OXYGEN CONCENTRATOR
K121260 · CAW
Vbox, Inc.
Anesthesiology · 148d
Cleared Sep 17, 2012
SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
K122506 · DQX
Surefire Medical, Inc.
Cardiovascular · 31d
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 Sep 05, 2012
TERUMO SURFLASH SAFETY I.V. CATHETER
K122544 · FOZ
Terumo Corporation
General Hospital · 15d
Cleared Aug 20, 2012
WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
K121720 · DWJ
Welkins, LLC
Cardiovascular · 69d
Cleared Aug 16, 2012
DX-D IMAGING PACKAGE
K121095 · MQB
Agfa Healthcare N.V.
Radiology · 127d
Cleared Aug 15, 2012
EXINI
K122205 · LLZ
Exini Diagnostics AB
Radiology · 21d
Cleared Aug 15, 2012
VISI MOBILE MONITORING SYSTEM
K122036 · MWI
Sotera Wireless, Inc.
Cardiovascular · 35d
Cleared Aug 14, 2012
TABLET COMMANDER
K122285 · DRG
Cardiocom, LLC
Cardiovascular · 15d
Cleared Aug 14, 2012
VIALOK SINGLE VIAL ACCESS DEVICE VENTED
K122265 · LHI
Yukon Medical, LLC
General Hospital · 15d
Cleared Aug 13, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
K120446 · FDS
Fujinon, Inc.
Radiology · 181d
Cleared Jul 30, 2012
PLATO MICROCATH 27 MICROCATHETER
K121734 · DQO
Scientia Vascular, LLC
Cardiovascular · 47d
Cleared Jul 20, 2012
CR 10-X DIGITIZER
K121948 · MQB
Agfa Healthcare N.V.
Radiology · 17d
Cleared Jul 11, 2012
LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEM
K121838 · MQB
Liebel-Flarsheim
Radiology · 19d
Cleared Jul 10, 2012
V5MS TRANSDUCER
K121807 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Jul 03, 2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K121871 · MWI
Airstrip Technologies, LP
Cardiovascular · 6d
Cleared Jul 02, 2012
ASTHMAPOLIS SYSTEM
K121609 · CAF
Reciprocal Labs Corporation
Anesthesiology · 31d
Cleared Jun 22, 2012
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND...
K121699 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Jun 22, 2012
ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND...
K121646 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 17d