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"
625–648 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 06, 2007
QLAB QUANTIFICATION
K070792 · LLZ
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Jan 26, 2007
ATRICURE ABLATION SYSTEM
K063630 · GEI
AtriCure, Inc.
General & Plastic Surgery · 51d
Cleared Jan 04, 2007
ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM
K063761 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Jan 04, 2007
ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5
K063559 · LNH
Philips Medical Systems
Radiology · 38d
Cleared Nov 21, 2006
EXCELART VANTAGE ATLAS, MODEL MRT-1503
K063361 · LNH
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 09, 2006
CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION
K063241 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 03, 2006
TSX-301A, AQUILION ONE CT SYSTEM
K063189 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 03, 2006
MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION
K063184 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 02, 2006
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0
K063130 · IYN
Toshibamedical Systems Corporation
Radiology · 20d
Cleared Oct 11, 2006
CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
K062727 · GCJ
Medtronic Vascular
General & Plastic Surgery · 28d
Cleared Sep 27, 2006
CKIS-004A INJECTOR SYNCHRONIZATION OPTION
K061976 · DXT
Toshiba America Medical Systems, In.C
Radiology · 76d
Cleared Sep 21, 2006
EP NAVIGATOR SOFTWARE
K062650 · LLZ
Philips Medical Systems
Radiology · 14d
Cleared Aug 21, 2006
VITREAACCESS, VERSION 1.0
K062328 · LLZ
Vital Images, Inc.
Radiology · 11d
Cleared Aug 18, 2006
HD11 DIAGNOSTIC ULTRASOUND SYSTEM
K062247 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Aug 10, 2006
VITAL CONNECT 4.0
K062154 · LLZ
Vital Images, Inc.
Radiology · 13d
Cleared Jul 21, 2006
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K061946 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 11, 2006
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K061788 · OMP
Boehringer Laboratories
General & Plastic Surgery · 15d
Cleared Jun 27, 2006
VITREA, VERSION 3.9
K061624 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared Jun 22, 2006
NEMIO XG, SAA-580A
K061605 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared May 30, 2006
QLAB QUANTIFICATION SOFTWARE
K061396 · LLZ
Philips Ultrasound, Inc.
Radiology · 11d
Cleared May 12, 2006
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
K061187 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Mar 09, 2006
VITREA2 VERSION 3.8.1
K060378 · LLZ
Vital Images, Inc.
Radiology · 23d
Cleared Mar 03, 2006
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K060277 · JCX
Boehringer Laboratories
General & Plastic Surgery · 29d
Cleared Jan 18, 2006
EXCELART VANTAGE ZGV
K060003 · LNH
Toshibamedical Systems Corporation
Radiology · 15d