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"
649–672 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 12, 2013
UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM
K130803 · IYN
Samsung Medison Co., Ltd.
Radiology · 21d
Cleared Apr 09, 2013
DEVON CIRONA 6100 DVT
K130571 · JOW
Devon Medical, Inc.
Cardiovascular · 36d
Cleared Apr 03, 2013
SPEQRT ULTRASOUND SYSTEM
K130659 · IYN
Signostics Pty, Ltd.
Radiology · 22d
Cleared Mar 28, 2013
BOEHRINGER GASTRIC SIZING TUBE
K130483 · KNT
Boehringer Laboratories, LLC
Gastroenterology & Urology · 31d
Cleared Mar 25, 2013
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K130754 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 6d
Cleared Mar 25, 2013
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
K130173 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 60d
Cleared Mar 21, 2013
ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM
K130619 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Mar 20, 2013
MIRADA RTX
K130393 · LLZ
Mirada Medical, Ltd.
Radiology · 33d
Cleared Mar 08, 2013
ENDOSEE MODEL 8000 U-SCOPE
K123151 · HIH
Endosee Corp
Obstetrics & Gynecology · 150d
Cleared Feb 14, 2013
CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE
K123647 · JOW
Devon Medical, Inc.
Cardiovascular · 79d
Cleared Feb 12, 2013
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
K123544 · LIT
Ev3, Inc.
Cardiovascular · 85d
Cleared Jan 23, 2013
FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)
K123310 · GEI
Utah Medical Products, Inc.
General & Plastic Surgery · 90d
Cleared Jan 14, 2013
QXMEDICAL ACCESS & SUPPORT CATHETER
K123311 · DQY
Qxmedical, LLC
Cardiovascular · 81d
Cleared Jan 03, 2013
NEO ERCP GUIDEWIRE
K123439 · OCY
Neometrics, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 21, 2012
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM
K123754 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Dec 13, 2012
PRESTO 1000 SYSTEM
K123565 · IYN
Physiosonics, Inc.
Radiology · 23d
Cleared Dec 13, 2012
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
K122535 · EOQ
Fujifilm Medical System U.S.A., Inc.
Ear, Nose, Throat · 115d
Cleared Dec 05, 2012
ACUSON
K123622 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared Nov 20, 2012
3M TRUE DEFINITION SCANNER
K122467 · NOF
3M Company
Dental · 99d
Cleared Nov 02, 2012
SURFFLASH(R) PLUS SAFETY I.V. CATHETER
K123267 · FOZ
Kofu Factory of Terumo Corp.
General Hospital · 14d
Cleared Nov 02, 2012
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
K122938 · NFJ
Carl Zeiss Meditec, AG
Ophthalmic · 39d
Cleared Oct 31, 2012
MULTIFLEX TINNITUS TECHNOLOGY
K122876 · KLW
Starkey Laboratories
Ear, Nose, Throat · 42d
Cleared Oct 26, 2012
ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
K123001 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Oct 22, 2012
ATLAS GOLD PTA DILATATION CATHETER
K122984 · LIT
C.R. Bard, Inc.
Cardiovascular · 26d