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"
649–672 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 15, 2005
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
K052632 · LLZ
Vital Images, Inc.
Radiology · 80d
Cleared Nov 18, 2005
ENCOMPASS SOFTWARE PACKAGE
K053043 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 21d
Cleared Oct 27, 2005
FOURSIGHT VIEWTOOL IMAGE VIEWER
K052895 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Oct 26, 2005
MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR
K052884 · OWB
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Oct 25, 2005
ATRICURE TRANSPOLAR SYSTEM
K052893 · GEI
AtriCure, Inc.
General & Plastic Surgery · 11d
Cleared Aug 15, 2005
ENSITE VERISMO SOFTWARE
K051840 · LLZ
St Jude Medical
Radiology · 39d
Cleared Jul 15, 2005
TSX-101A/H AQUILION 64 SP CT SCANNER
K051833 · JAK
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Jul 14, 2005
QD KNEE/FOOT COIL, MODEL MJQJ-147A
K051763 · MOS
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 17, 2005
FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A
K051500 · IYO
Toshiba America Medical Systems, In.C
Radiology · 10d
Cleared Jun 13, 2005
ATRICURE ISOLATOR TRANSPOLAR PEN
K050459 · OCL
AtriCure, Inc.
Cardiovascular · 110d
Cleared May 13, 2005
ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
K051139 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 9d
Cleared Mar 24, 2005
MEGA POWER ELECTROSURGICAL GENERATOR
K050579 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 17d
Cleared Mar 10, 2005
TSX-201A AQUILION LB CT SCANNER
K050458 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Feb 23, 2005
XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A
K050380 · IYN
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Feb 15, 2005
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
K050240 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared Feb 09, 2005
MULTIDIAGNOST ELEVA
K050151 · KPR
Philips Medical Systems North...
Radiology · 16d
Cleared Feb 01, 2005
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
K050102 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 14d
Cleared Jan 13, 2005
SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM
K050034 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 6d
Cleared Dec 15, 2004
VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM
K043333 · LLZ
Vital Images, Inc.
Radiology · 12d
Cleared Nov 18, 2004
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A
K043111 · JAK
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Nov 17, 2004
NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A
K043078 · IYO
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Nov 16, 2004
SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM
K043016 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 27, 2004
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K042833 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 20, 2004
MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
K042770 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d