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"
961–984 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 02, 2008
VIVID I AND VIVID Q
K082374 · IYN
Ge Medical Systems Israel,...
Radiology · 15d
Cleared Aug 29, 2008
DSA 2000EX
K082341 · LLZ
Eigen, LLC
Radiology · 14d
Cleared Aug 27, 2008
ROLL-X GUIDEWIRE
K082304 · DQX
St Jude Medical
Cardiovascular · 14d
Cleared Aug 26, 2008
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
K081516 · CBP
Medsource International, LLC
Anesthesiology · 88d
Cleared Aug 25, 2008
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
K082098 · IYN
Sonosite,Inc.
Radiology · 31d
Cleared Aug 21, 2008
PCA-8000A, MARK 11, PET / CT SYSTEM
K082244 · KPS
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Aug 15, 2008
ANEROID SPHYGMOMANOMETER, MODEL KT-A01
K081951 · DXQ
Wenzhou Kindcare Import & Export Co.,...
Cardiovascular · 37d
Cleared Aug 12, 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
K082119 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Aug 12, 2008
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY
K081939 · GEX
Omniguide, Inc.
General & Plastic Surgery · 35d
Cleared Aug 01, 2008
FIATLUX VISUALIZE
K082041 · LLZ
Fiatlux Imaging, Inc.
Radiology · 14d
Cleared Jul 28, 2008
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
K081976 · LLZ
Agfa Healthcare Corporation
Radiology · 17d
Cleared Jul 25, 2008
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
K081963 · MQB
Agfa Healthcare Corporation
Radiology · 15d
Cleared Jul 11, 2008
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
K081802 · ITX
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Jul 10, 2008
MODEL 7340 ULTRASOUND SYSTEM
K081794 · IYN
Esaote, S.P.A.
Radiology · 15d
Cleared Jul 09, 2008
NUWAV
K081781 · IYO
Laborie Medical Technologies, Corp.
Radiology · 15d
Cleared Jul 02, 2008
SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM
K081676 · IYN
Medison Co., Ltd.
Radiology · 15d
Cleared Jun 24, 2008
HD15 DIAGNOSTIC ULTRASOUND SYSTEM
K081661 · IYN
Philips Ultrasound, Inc.
Radiology · 11d
Cleared Jun 23, 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
K081624 · MQB
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Jun 23, 2008
INFX-8000C (INFINIX CC-I AND VC-I)
K081621 · JAA
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 18, 2008
PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201
K081340 · MOS
Shanghai Chenguang Medical...
Radiology · 36d
Cleared Jun 18, 2008
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE...
K081322 · MOS
Shanghai Chenguang Medical...
Radiology · 37d
Cleared Jun 17, 2008
INFX-8000V, INFINIX-CFI AND INFINIX VFI
K081582 · JAA
Toshiba America Medical Systems, In.C
Radiology · 12d
Cleared Jun 17, 2008
DC NEURO
K081262 · LLZ
Invivo Corporation
Radiology · 43d
Cleared Jun 11, 2008
CSBP-001A BODY ORGAN PERFUSION SYSTEM
K081482 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d