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"
553–576 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 07, 2014
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
K141846 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 05, 2014
RHYTHMSTAR SYSTEM
K141813 · DXH
RhythMedix, LLC
Cardiovascular · 29d
Cleared Jul 31, 2014
ENDOSIZE
K141475 · LLZ
Therenva Sas
Radiology · 57d
Cleared Jul 25, 2014
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
K141838 · GEX
Regulatory Technology Services, LLC
General & Plastic Surgery · 17d
Cleared Jul 18, 2014
ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM
K141641 · IYN
Zonare Medical Systems, Inc.
Radiology · 29d
Cleared Jul 11, 2014
ESIE APPS SUITE
K141554 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jul 11, 2014
MYLABSIX ULTRASOUND SYSTEM
K141486 · IYN
Esaote Europe B.V.
Radiology · 36d
Cleared Jul 02, 2014
RS80A DIAGNOSTIC ULTRASOUND SYSTEM
K141620 · IYN
Samsung Medison Co., Ltd.
Radiology · 15d
Cleared Jul 02, 2014
VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
K141369 · IYN
Philips Ultrasound, Inc.
Radiology · 40d
Cleared Jun 27, 2014
DEVON CIRONA 6200 DVT
K141578 · JOW
Devon Medical
Cardiovascular · 14d
Cleared Jun 20, 2014
SUREFLEX LITHOTRIPSY LASER FIBERS
K140679 · GEX
American Medical Systems
General & Plastic Surgery · 94d
Cleared Jun 04, 2014
VTI SUCTION IRRIGATION SYSTEM
K141323 · GCJ
Regulatory Technology Services, LLC
General & Plastic Surgery · 15d
Cleared May 30, 2014
TERASON USMART3300 ULTRASOUND SYSTEM
K140773 · IYN
Teratech Corp.
Radiology · 63d
Cleared May 20, 2014
PRIME ZOOM STRETCHER
K140095 · INK
Stryker Corporation
Physical Medicine · 126d
Cleared May 14, 2014
M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV...
K141010 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 26d
Cleared May 08, 2014
FILTEK BULK FILL POSTERIOR RESTROATIVE
K141081 · EBF
3M Espe Dental Products
Dental · 13d
Cleared May 05, 2014
HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM
K140899 · IYO
Halo Medical Technologies, LLC
Radiology · 27d
Cleared May 02, 2014
PROPELLER SYSTEM - MODEL 2
K140638 · CAF
Reciprocal Labs Corporation
Anesthesiology · 51d
Cleared Apr 30, 2014
ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS
K140959 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Apr 25, 2014
TERASON USMART3400 ULTRASOUND SYSTEM
K140834 · IYN
Teratech Corp.
Radiology · 23d
Cleared Apr 17, 2014
Q-STATION
K140808 · LLZ
Philips Ultrasound, Inc.
Radiology · 16d
Cleared Apr 15, 2014
MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR
K140831 · FPA
Care Fusion
General Hospital · 13d
Cleared Apr 11, 2014
AZE PHOENIX SOFTWARE
K133521 · LLZ
Aze, Ltd.
Radiology · 147d
Cleared Apr 10, 2014
DUALGUARD
K140473 · CCK
Flexicare Medical, Ltd.
Anesthesiology · 44d