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"
601–624 of 681
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 08, 2008
APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM
K080160 · IYN
Toshiba America Medical Systems, In.C
Radiology · 16d
Cleared Jan 22, 2008
VANTAGE TITAN, MODEL MRT-1504/S3
K080038 · LNH
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Dec 20, 2007
XIDF-100A/B1 IMAGE PROCESSOR
K073259 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 30d
Cleared Nov 21, 2007
JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X
K073081 · LNH
Toshiba America Medical Systems, In.C
Radiology · 20d
Cleared Nov 16, 2007
DRAD-3000E, RADREX-I
K073165 · MQB
Toshiba America Medical Systems, In.C
Radiology · 7d
Cleared Nov 13, 2007
ACUSON S2000 ULTRASOUND SYSTEM
K072786 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Nov 01, 2007
CSNP-001A NEURO PACKAGE
K072693 · JAK
Toshiba America Medical Systems, In.C
Radiology · 38d
Cleared Oct 29, 2007
MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00
K072918 · ITX
Toshibamedical Systems Corporation
Radiology · 14d
Cleared Oct 24, 2007
APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
K072826 · ITX
Toshiba America Medical Systems, In.C
Radiology · 21d
Cleared Oct 05, 2007
CSCS-001A CALCIUM SCORING PACKAGE
K072737 · JAK
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Oct 02, 2007
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
K072606 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Sep 25, 2007
SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM
K072541 · ITX
Senorx, Inc.
Radiology · 15d
Cleared Sep 21, 2007
VISULAS TRION
K072514 · GEX
Carl Zeiss Meditec, AG
General & Plastic Surgery · 14d
Cleared Sep 20, 2007
DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30
K072034 · GEX
Quanta System Spa
General & Plastic Surgery · 57d
Cleared Sep 13, 2007
BRK TRANSSEPTAL NEEDLE
K072278 · DRC
St Jude Medical
Cardiovascular · 28d
Cleared Aug 29, 2007
ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM
K072266 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Aug 03, 2007
MYLAB30, MODEL 7300
K071996 · IYO
Esaote, S.P.A.
Radiology · 8d
Cleared Jul 30, 2007
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0
K072000 · IYN
Toshiba America Medical Systems, In.C
Radiology · 7d
Cleared Jun 05, 2007
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K071462 · ETW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 11d
Cleared May 30, 2007
VITAL CONNECT 4.1
K071362 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared May 25, 2007
VITREA VERSION 4.0
K071331 · LLZ
Vital Images, Inc.
Radiology · 14d
Cleared May 22, 2007
SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
K071314 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared May 18, 2007
SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY
K071229 · JAQ
Senorx, Inc.
Radiology · 15d
Cleared Apr 24, 2007
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261
K070311 · GEI
Medtronic Vascular
General & Plastic Surgery · 82d