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"
721–744 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 03, 2012
TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS
K112953 · IYN
Teratech Corp.
Radiology · 122d
Cleared Jan 25, 2012
SONIXTABLET ULTRASOUND SCANNER
K113663 · IYN
Ultrasonix Medical Corporation
Radiology · 43d
Cleared Dec 29, 2011
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
K113680 · IYO
Soma Access Systems, LLC
Radiology · 14d
Cleared Dec 29, 2011
MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM
K113381 · IYN
Samsung Medison Co., Ltd.
Radiology · 43d
Cleared Dec 16, 2011
CLEARSTART SVM SYSTEM
K113541 · LLZ
Intio, Inc.
Radiology · 15d
Cleared Dec 14, 2011
TERUMO ASPRIATION CATHETER
K112382 · QEZ
Terumo Medical Corporation
Cardiovascular · 118d
Cleared Dec 07, 2011
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K113179 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 40d
Cleared Dec 06, 2011
DENTAL 3D PLANNING SOFTWARE
K113404 · LLZ
Symbyo Dental, LLC
Radiology · 18d
Cleared Nov 23, 2011
CAROTID COIL GE 1.5T
K113280 · MOS
Tursiop Technologies, LLC
Radiology · 16d
Cleared Nov 17, 2011
MOBCARDIO SYSTEM
K113234 · DPS
Mobhealth Incorporation
Cardiovascular · 15d
Cleared Nov 15, 2011
SONOSITE EDGE ULTRASOUND SYSTEM
K113156 · IYO
Sonosite,Inc.
Radiology · 20d
Cleared Nov 14, 2011
ARGES IMAGING CONTRAST SPRAY
K113263 · ELW
Arges Imaging, Inc.
Dental · 10d
Cleared Oct 27, 2011
DX-D 600
K112670 · KPR
Agfa Healthcare N.V.
Radiology · 43d
Cleared Oct 12, 2011
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K112646 · IYN
Samsung Medison Co., Ltd.
Radiology · 30d
Cleared Oct 12, 2011
LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE
K112051 · LLZ
Broncus Technologies, Inc.
Radiology · 86d
Cleared Sep 27, 2011
SONIX ULTRASOUND SCANNER
K112726 · IYN
Ultrasonix Medical Corporation
Radiology · 7d
Cleared Sep 16, 2011
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K112596 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 9d
Cleared Aug 31, 2011
S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
K112376 · FLL
Circa Scientific, LLC
General Hospital · 14d
Cleared Aug 29, 2011
ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
K112339 · IYN
Samsung Medison Co., Ltd.
Radiology · 14d
Cleared Aug 26, 2011
COMFORTGLIDE INTERMITENT CATHETER
K112137 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 31d
Cleared Aug 25, 2011
YOULASER CO2 LASER SYSTEM
K111592 · GEX
Quanta System Spa
General & Plastic Surgery · 79d
Cleared Aug 17, 2011
CROSSER RECANALIZATION SYSTEM
K112308 · PDU
C.R. Bard, Inc.
Cardiovascular · 6d
Cleared Aug 05, 2011
IMPAX NEXT GENERATION
K111945 · LLZ
Agfa Healthcare N.V.
Radiology · 28d
Cleared Aug 05, 2011
IBIS EXPLORER AND MARKUP SOFTWARE
K111319 · LLZ
Medqia
Radiology · 87d