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"
265–288 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 06, 2020
EPIQ Diagnostic Ultrasound System
K200304 · IYN
Philips Ultrasound, Inc.
Radiology · 29d
Cleared Feb 24, 2020
3D Predict
K200214 · NXC
3D Smile USA, Inc.
Dental · 27d
Cleared Feb 21, 2020
LightForce Orthodontic System (LFO System)
K200148 · NJM
Lightforce Orthodontics
Dental · 30d
Cleared Feb 19, 2020
ClearCam System
K200228 · GCJ
Clearcam, LLC
General & Plastic Surgery · 20d
Cleared Feb 18, 2020
Collaboration Live
K200179 · LLZ
Philips Health Care
Radiology · 25d
Cleared Jan 28, 2020
Terason uSmart3200T Ultrasound System
K193510 · IYN
Teratech Corporation
Radiology · 41d
Cleared Jan 17, 2020
AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX
K193509 · DYB
Acutus Medical, Inc.
Cardiovascular · 30d
Cleared Dec 31, 2019
AutoMIStar
K192912 · LLZ
Apollo Medical Imaging Technology...
Radiology · 77d
Cleared Dec 27, 2019
UroNav System
K193403 · LLZ
Invivo Corporation
Radiology · 21d
Cleared Dec 27, 2019
True 3D Viewer Software
K193149 · LLZ
Echopixel, Inc.
Radiology · 44d
Cleared Dec 20, 2019
DenMat Orthodontic Aligners
K192470 · NXC
Denmat Holdings, LLC
Dental · 102d
Cleared Dec 13, 2019
CoreLite X-Ray Specimen Cabinet
K193317 · MWP
Cirdan Imaging Limited
Radiology · 14d
Cleared Dec 13, 2019
CrossTorq 14 Guidewire
K193194 · DQX
Scientia Cardio Access, LLC
Cardiovascular · 24d
Cleared Dec 03, 2019
TriSalus Infusion System
K193107 · KRA
Trisalus Life Sciences
Cardiovascular · 25d
Cleared Nov 19, 2019
Dolphin Medical Imaging USB Ultrasound System
K192573 · IYO
Dolphin Medical Imaging, LLC
Radiology · 62d
Cleared Nov 13, 2019
Piper GO-IO Intraosseous Infusion System
K191976 · FMI
Piper Access, LLC
General Hospital · 112d
Cleared Nov 05, 2019
Suglue 3
K192992 · EMA
3M Deutschland GmbH
Dental · 11d
Cleared Oct 31, 2019
ADH19
K192961 · KLE
3M Deutschland GmbH
Dental · 9d
Cleared Oct 22, 2019
ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic...
K192835 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Oct 09, 2019
DynaCAD
K192200 · LLZ
Invivo Corporation
Radiology · 57d
Cleared Oct 09, 2019
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
K191687 · DQX
Phenox Limited
Neurology · 107d
Cleared Oct 04, 2019
Steerable Introducer 12F
K192422 · DRA
Freudenberg Medical, LLC
Cardiovascular · 30d
Cleared Oct 03, 2019
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
K192318 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 38d
Cleared Oct 01, 2019
ExactVu High Resolution Micro-Ultrasound System
K192303 · IYN
Exact Imaging, Inc.
Radiology · 39d