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"
601–624 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 22, 2013
SENSE-4BABY SYSTEM
K132918 · HGM
Sense4baby , Inc.
Obstetrics & Gynecology · 66d
Cleared Nov 19, 2013
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
K132779 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 75d
Cleared Nov 15, 2013
SHARPSOLOGY 2
K133031 · MMK
Industrial Water Solutions, Inc.
General Hospital · 50d
Cleared Nov 04, 2013
X-PORTE ULTRASOUND SYSTEM
K133134 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d
Cleared Oct 28, 2013
TX WHEELCHAIR CHASSIS
K131336 · IOR
Jcm Seating Solutions, Ltd.
Physical Medicine · 172d
Cleared Oct 24, 2013
ACUSON S1000 / S2000 / S3000
K132804 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 48d
Cleared Oct 15, 2013
LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
K131234 · EOQ
Broncus Medical, Inc.
Ear, Nose, Throat · 167d
Cleared Oct 11, 2013
CLASSIC INTERMITTENT CATHETER
K132619 · EZD
Flexicare Medical, Ltd.
Gastroenterology & Urology · 51d
Cleared Oct 04, 2013
SMARTSITE VIALSHIELD
K132863 · LHI
Yukon Medical, LLC
General Hospital · 22d
Cleared Oct 04, 2013
UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM
K132861 · IYN
Samsung Medison Co., Ltd.
Radiology · 22d
Cleared Oct 04, 2013
VITAHEAT PATIENT WARMING SYSTEM
K132454 · DWJ
Vitaheat Medical, LLC
Cardiovascular · 59d
Cleared Sep 26, 2013
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
K132777 · LIT
Ev3, Inc.
Cardiovascular · 21d
Cleared Sep 04, 2013
5MP GRAYSCALE LCD DISPLAY
K132610 · LLZ
Shenzhen Beacon Display Technology...
Radiology · 15d
Cleared Aug 29, 2013
MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR
K132587 · LLZ
Ned Display Solutions , Ltd.
Radiology · 13d
Cleared Aug 29, 2013
MZ1000
K132413 · FPA
Care Fusion
General Hospital · 27d
Cleared Aug 21, 2013
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM
K132304 · IYN
Philips Ultrasound, Inc.
Radiology · 28d
Cleared Aug 20, 2013
UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM
K132228 · IYO
Samsung Medison Co., Ltd.
Radiology · 34d
Cleared Aug 15, 2013
DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
K132341 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 20d
Cleared Aug 15, 2013
CONTRAST CONSERVATION SYSTEM
K131478 · DXT
Osprey Medical, Inc.
Cardiovascular · 85d
Cleared Aug 09, 2013
QLAB QUANTIFICATION SOFTWARE
K132165 · LLZ
Philips Ultrasound, Inc.
Radiology · 28d
Cleared Aug 02, 2013
SIDEKICK AND USHER SUPPORT CATHETERS
K131493 · DQY
C.R. Bard, Inc.
Cardiovascular · 71d
Cleared Aug 01, 2013
MYOVISION 3.0 WIREFREE SYSTEM
K123399 · IKN
Precision Biometrics, Inc.
Neurology · 269d
Cleared Jul 25, 2013
DUOFLEX COIL SUITE (1.5T)
K130706 · MOS
Mr Instruments, Inc.
Radiology · 132d
Cleared Jul 25, 2013
CARE SU01A SUCTION ASPIRATOR
K130001 · JCX
Foshan Care Medical Technology Co., Ltd.
General & Plastic Surgery · 204d