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"
1081–1104 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 29, 2006
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER
K063141 · GEX
Omniguide, Inc.
General & Plastic Surgery · 44d
Cleared Nov 29, 2006
BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP
K063060 · GEX
Blueshine Srl
General & Plastic Surgery · 55d
Cleared Nov 21, 2006
EXCELART VANTAGE ATLAS, MODEL MRT-1503
K063361 · LNH
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 15, 2006
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
K063302 · EIA
Shanghai Dental Instrument Factory
Dental · 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 27, 2006
GYNESONICS EC6 TRANSDUCER
K061153 · ITX
Gynesonics, Inc.
Radiology · 184d
Cleared Oct 26, 2006
CST61 HIGH SPEED TURBINE HANDPIECE
K063110 · EFB
Shanghai Dental Instrument Factory
Dental · 15d
Cleared Oct 11, 2006
CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE
K062727 · GCJ
Medtronic Vascular
General & Plastic Surgery · 28d
Cleared Oct 03, 2006
SANDMAN POCKET
K061996 · MNR
Eb Neuro S.P.A.
Anesthesiology · 81d
Cleared Sep 29, 2006
NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS FT-500R/L AND FT-700R/L
K062462 · DXN
Jawon Medical Co., Ltd.
Cardiovascular · 36d
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 Sep 21, 2006
OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM
K062423 · GEX
Omniguide, Inc.
General & Plastic Surgery · 34d
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 Aug 04, 2006
PRODRIVE SYSTEMS REPLACEMENT TURBINE
K062219 · EFB
Prodrive Systems, Inc.
Dental · 2d
Cleared Jul 21, 2006
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
K061946 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 19, 2006
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
K061909 · GEX
Omniguide, Inc.
General & Plastic Surgery · 13d
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