FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

484 results for "regulatory technology services, llc"
241–264 of 484
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 26, 2020
ACUSON Juniper Diagnostic Ultrasound System
K201130 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared May 14, 2020
PercuNav Image Fusion and Interventional Navigation
K201053 · JAK
Philips Ultrasound, Inc.
Radiology · 23d
Cleared May 08, 2020
Sonosite PX Ultrasound System
K200964 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d
Cleared May 02, 2020
BOSS Balloon Guide Catheter
K200910 · QJP
Marblehead Medical
Neurology · 26d
Cleared Apr 29, 2020
Evry
K200327 · LNH
Synaptive Medical, Inc.
Radiology · 79d
Cleared Apr 27, 2020
Percutaneous Introducer
K200624 · BSO
Epimed International, Inc.
Anesthesiology · 48d
Cleared Apr 15, 2020
ACUSON Sequoia Diagnostic Ultrasound System
K200707 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Mar 31, 2020
AquaFlate Pre-Filled Sterile Water Syringe 10mL
K200556 · EZL
H R Pharmaceuticals, Inc.
Gastroenterology & Urology · 28d
Cleared Mar 24, 2020
FloPatch (FP120)
K200337 · DPW
Flosonics Medical (R/A 1929803...
Cardiovascular · 42d
Cleared Mar 17, 2020
EndoTool IV 1.10
K200443 · NDC
Monarch Medical Technologies, LLC
Chemistry · 22d
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