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"
337–360 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 23, 2018
Xperius Ultrasound System
K182529 · IYN
Philips Ultrasound, Inc.
Radiology · 39d
Cleared Oct 19, 2018
UroNav (Version 3.0)
K182561 · LLZ
Invivo Corporation
Radiology · 31d
Cleared Oct 11, 2018
Ormco Spark Aligner System
K182826 · NXC
Sybron Dental Specialties
Dental · 6d
Cleared Oct 04, 2018
HYBRID Guidewire
K182337 · MOF
Balt USA, LLC
Neurology · 37d
Cleared Sep 14, 2018
DizzyDoctor System 1.0.0
K182214 · GWN
Dizzydoctor Systems, LLC
Ear, Nose, Throat · 30d
Cleared Sep 11, 2018
AirStrip RPM InvisionHeart Adapter
K182226 · MWI
Airstrip Technologies, Inc.
Cardiovascular · 26d
Cleared Sep 07, 2018
Solstice SRS Immobilization System
K182079 · IYE
Medtec Inc. Dba Civco Medical Solutions
Radiology · 36d
Cleared Jul 30, 2018
Epiphany Cardio Server Mobile
K181720 · DQK
Epiphany Healthcare, LLC
Cardiovascular · 31d
Cleared Jul 27, 2018
EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic...
K181485 · IYN
Philips Ultrasound, Inc.
Radiology · 51d
Cleared Jul 26, 2018
RadialSeal Introducer Kit
K181855 · DYB
Great Batch Medical
Cardiovascular · 15d
Cleared Jul 26, 2018
Level 1 Convective Warmer
K181699 · DWJ
Smiths Medical Asd, Inc.
Cardiovascular · 29d
Cleared Jul 10, 2018
Uscan
K181574 · IYO
EchoNous, Inc.
Radiology · 25d
Cleared Jul 10, 2018
Workflow Box
K181572 · QKB
Mirada Medical, Ltd.
Radiology · 26d
Cleared Jun 18, 2018
Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral...
K181484 · EBF
Zirkonzahn Srl
Dental · 13d
Cleared Jun 13, 2018
EcoVue Sterile and Non-Sterile Ultrasound Gels
K181363 · MUI
H R Pharmaceuticals, Inc.
Radiology · 21d
Cleared Jun 13, 2018
Signature Orthodontic System
K181271 · NJM
Signature Orthodontics
Dental · 30d
Cleared Jun 07, 2018
QLAB Advanced Quantification Software
K181264 · LLZ
Philips Ultrasound, Inc.
Radiology · 24d
Cleared May 31, 2018
ACUSON SC2000 Diagnostic Ultrasound System
K181098 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared May 15, 2018
5D Viewer
K180883 · LLZ
Samsung Medison Co., Ltd.
Radiology · 41d
Cleared May 14, 2018
Clarius Ultrasound Scanner
K180799 · IYN
Clarius Mobile Health Corp.
Radiology · 48d
Cleared May 09, 2018
VSI Micro-Introducer Kit
K180913 · DYB
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared May 03, 2018
Medtronic Confida Brecker Guidewire
K181001 · DQX
Medtronic Core Valve, LLC
Cardiovascular · 17d
Cleared Apr 30, 2018
ExactVu High Resolution Micro-Ultrasound System
K180636 · IYO
Exact Imaging, Inc.
Radiology · 49d
Cleared Apr 13, 2018
SonoSite iViz Ultrasound System
K180704 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 25d