FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

750 results for "Regulatory Technology Services, LLC"
529–552 of 750
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 25, 2011
ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
K103397 · IYN
Medison Co., Ltd.
Radiology · 98d
Cleared Feb 08, 2011
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
K110202 · ITX
Fujifilm Medical System U.S.A., Inc.
Radiology · 15d
Cleared Feb 02, 2011
FINESS ENDOSCOPE STERILIZATION TRAY
K103213 · KCT
Entellus Medical, Inc.
General Hospital · 93d
Cleared Jan 26, 2011
VANTAGE VIEW SYSTEM
K110085 · DXJ
St Jude Medical
Cardiovascular · 15d
Cleared Jan 25, 2011
Q-STATION
K103815 · LLZ
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Jan 20, 2011
QUANTA SYSTEM DUOLITE
K103539 · GEX
Quanta System Spa
General & Plastic Surgery · 49d
Cleared Jan 05, 2011
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
K103722 · ITX
Medison Co., Ltd.
Radiology · 15d
Cleared Jan 05, 2011
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K103618 · MCW
Ev3, Inc.
Cardiovascular · 26d
Cleared Jan 03, 2011
DX-D 100
K103597 · IZL
Agfa Healthcare N.V.
Radiology · 26d
Cleared Dec 22, 2010
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K102391 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 121d
Cleared Dec 13, 2010
VASCUTRAK PTA DILATATION CATHETER
K103459 · PNO
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Dec 10, 2010
QUANTA CYBER TM 150W
K102749 · GEX
Quanta System Spa
General & Plastic Surgery · 78d
Cleared Dec 08, 2010
SEEKER CROSSING SUPPORT CATHETER
K103367 · DQY
Bard Peripheral Vascular, Inc.
Cardiovascular · 22d
Cleared Dec 06, 2010
EVERCROSS 0.035 OTW PTA DILATION CATHETER
K103322 · LIT
Ev3, Inc.
Cardiovascular · 24d
Cleared Nov 19, 2010
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
K102390 · IYN
Sonosite,Inc.
Radiology · 88d
Cleared Oct 29, 2010
DX-D 300
K103050 · KPR
Agfa Healthcare N.V.
Radiology · 14d
Cleared Sep 23, 2010
NEOWIRE PTA/PTCA GUIDEWIRE
K101729 · DQX
Neometrics, Inc.
Cardiovascular · 94d
Cleared Sep 22, 2010
ENSITE VERISMO SEGMENTATION TOOL V.2.0
K101697 · LLZ
St Jude Medical
Radiology · 98d
Cleared Sep 20, 2010
SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K102017 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Aug 12, 2010
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND...
K101757 · ITX
Sonosite,Inc.
Radiology · 50d
Cleared Aug 09, 2010
ALLURA XPER OR TABLE SERIES
K102005 · OWB
Philips Medical Systems North...
Radiology · 25d
Cleared Aug 06, 2010
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K102065 · IYN
Medison Co., Ltd.
Radiology · 14d
Cleared Aug 06, 2010
HEADWAY 17 ADVANCED MICROCATHETER
K101542 · DQY
MicroVention, Inc.
Cardiovascular · 64d
Cleared Jul 22, 2010
QUANTA DIODE LASER SYSTEM
K100558 · GEX
Quanta System Spa
General & Plastic Surgery · 143d