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"
577–600 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 04, 2014
CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT
K132381 · LNH
Clearmri Solutions, Inc.
Radiology · 247d
Cleared Mar 26, 2014
PEREGRINE SYSTEM INFUSION CATHETER
K140637 · KRA
Ablative Solutions, Inc.
Cardiovascular · 14d
Cleared Mar 25, 2014
SAFETY BIOPSY NEEDLE SYSTEM
K140137 · FCG
Pfm Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Mar 21, 2014
TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
K140524 · IYN
Teratech Corp.
Radiology · 17d
Cleared Mar 07, 2014
IMPAX VOLUME VIEWING 3.0
K133135 · LLZ
Agfa Healthcare N.V.
Radiology · 154d
Cleared Mar 06, 2014
O2 NASAL CANNULA WITH CO2 MONITORING
K140113 · CCK
Flexicare Medical, Ltd.
Anesthesiology · 50d
Cleared Mar 03, 2014
HEARTSCAN SOFTWARE
K133937 · LLZ
Morpheus Imaging, Inc.
Radiology · 70d
Cleared Feb 27, 2014
TARGET3D FUSION
K140033 · LLZ
Convergent Life Sciences, Inc.
Radiology · 51d
Cleared Feb 26, 2014
EZONO 4000
K140254 · IYN
Ezono AG
Radiology · 26d
Cleared Feb 26, 2014
SUREFIRE GUIDING CATHETER
K140034 · DQY
Surefire Medical, Inc.
Cardiovascular · 50d
Cleared Feb 19, 2014
DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM
K140030 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 44d
Cleared Feb 14, 2014
AIRSTRIP REMOTE PATIENT MONITORING
K133450 · MWI
Airstrip Technologies, LP
Cardiovascular · 95d
Cleared Feb 10, 2014
IMRI 1.5T AND IMRI 3T S
K133692 · LNH
Imris, Inc.
Radiology · 70d
Cleared Feb 06, 2014
AIRSTRIP REMOTE PATIENT MONITORING
K133394 · MWI
Airstrip Technologies, LP
Cardiovascular · 93d
Cleared Jan 31, 2014
ENLIGHTN RENAL GUIDE CATHETER
K131592 · DQY
St. Jude Medical, Inc.
Cardiovascular · 242d
Cleared Jan 24, 2014
ATRICURE CRYO MODULE SYSTEM
K140058 · GEH
AtriCure, Inc.
General & Plastic Surgery · 14d
Cleared Jan 24, 2014
MACY CATHETER
K133881 · KNT
Hospi Corporation
Gastroenterology & Urology · 35d
Cleared Jan 17, 2014
NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
K133833 · IYN
Philips Ultrasound, Inc.
Radiology · 31d
Cleared Dec 31, 2013
M1 CAPNOGRAPHY MASK
K133806 · CCK
Monitor Mask, Inc.
Anesthesiology · 15d
Cleared Dec 27, 2013
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K133505 · IYN
Samsung Medison Co., Ltd.
Radiology · 43d
Cleared Dec 17, 2013
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP...
K132340 · FEQ
Erbe USA, Inc.
Gastroenterology & Urology · 144d
Cleared Dec 16, 2013
SONOSITE EDGE ULTRASOUND SYSTEM
K133454 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d
Cleared Nov 27, 2013
UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM
K133329 · IYN
Samsung Medison Co., Ltd.
Radiology · 29d
Cleared Nov 26, 2013
ASPIRE RX-LP6 ASPIRATION CATHETER
K131998 · QEZ
Control Medical Technology, LLC
Cardiovascular · 151d