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"
409–432 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 10, 2014
eSie Apps Suite
K143254 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 09, 2014
H60 V2.00 Diagnostic Ultrasound System
K143264 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
Cleared Nov 26, 2014
WS80A Diagnostic Ultrasound System
K143089 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Nov 20, 2014
MaxZero Administration Sets
K143234 · FPA
Care Fusion
General Hospital · 10d
Cleared Oct 28, 2014
Fortrex 0.035 OTW PTA Balloon Catheter
K142654 · LIT
Covidien, LLC
Cardiovascular · 40d
Cleared Oct 23, 2014
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
K142876 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Oct 10, 2014
Acuson SC2000 Diagnostic Ultrasound System
K142628 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 24d
Cleared Oct 03, 2014
UGEO PT60A Diagnostic Ultrasound System
K142466 · IYN
Samsung Medison Co., Ltd.
Radiology · 31d
Cleared Sep 24, 2014
Ultraverse 035 PTA Balloon Dilatation Catheter
K142261 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 41d
Cleared Sep 09, 2014
SC2000 and ACUSON X300 Diagnostic Ultrasound Systems
K142395 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Aug 07, 2014
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
K141846 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jul 25, 2014
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
K141838 · GEX
Regulatory Technology Services, LLC
General & Plastic Surgery · 17d
Cleared Jul 11, 2014
ESIE APPS SUITE
K141554 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jul 02, 2014
RS80A DIAGNOSTIC ULTRASOUND SYSTEM
K141620 · IYN
Samsung Medison Co., Ltd.
Radiology · 15d
Cleared Jul 02, 2014
VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
K141369 · IYN
Philips Ultrasound, Inc.
Radiology · 40d
Cleared Jun 04, 2014
VTI SUCTION IRRIGATION SYSTEM
K141323 · GCJ
Regulatory Technology Services, LLC
General & Plastic Surgery · 15d
Cleared May 20, 2014
PRIME ZOOM STRETCHER
K140095 · INK
Stryker Corporation
Physical Medicine · 126d
Cleared May 14, 2014
M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV...
K141010 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 26d
Cleared Apr 30, 2014
ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
K140959 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Apr 17, 2014
Q-STATION
K140808 · LLZ
Philips Ultrasound, Inc.
Radiology · 16d
Cleared Apr 15, 2014
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
K140831 · FPA
Care Fusion
General Hospital · 13d
Cleared Mar 07, 2014
IMPAX VOLUME VIEWING 3.0
K133135 · LLZ
Agfa Healthcare N.V.
Radiology · 154d
Cleared Feb 19, 2014
DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
K140030 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 44d
Cleared Jan 24, 2014
ATRICURE CRYO MODULE SYSTEM
K140058 · GEH
AtriCure, Inc.
General & Plastic Surgery · 14d