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"
361–384 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 12, 2018
Admiral Xtreme
K173515 · LIT
Medtronic Vascular
Cardiovascular · 149d
Cleared Apr 03, 2018
Surefire Spark Infusion System
K180677 · DQO
Surefire Medical, Inc.
Cardiovascular · 19d
Cleared Mar 16, 2018
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
K180404 · NJM
3M Healthcare
Dental · 30d
Cleared Mar 02, 2018
COMPACT TOUCH Ophthalmic Ultrasound System
K180265 · IYO
Quantel Medical
Radiology · 30d
Cleared Feb 16, 2018
Warrior 14 guidewire
K180128 · DQX
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Feb 07, 2018
ACUSON X800 Diagnostic Ultrasound System
K180067 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Feb 02, 2018
ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic...
K173981 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 35d
Cleared Feb 01, 2018
ACUSON P600 Diagnostic Ultrasound System
K180039 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Feb 01, 2018
ACUSON NX3 Diagnostic Ultrasound System
K173957 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Jan 22, 2018
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm,...
K173235 · DQX
Scientia Vascular, LLC
Cardiovascular · 109d
Cleared Jan 05, 2018
Sureclear aligners
K171860 · NXC
Emergo Global Consulting, LLC
Dental · 197d
Cleared Dec 15, 2017
Raider Guidewire
K173532 · DQX
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Dec 15, 2017
BD Nexiva Diffusics Closed IV Catheter Systems
K173354 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 51d
Cleared Dec 15, 2017
BioFlux Device
K172311 · DXH
Biotricity, Inc.
Cardiovascular · 136d
Cleared Nov 30, 2017
Endophys Pressure Sensing Sheath Kit- 8F
K173399 · DYB
Endophys Holdings, LLC
Cardiovascular · 30d
Cleared Nov 28, 2017
DuoFLEX Coil Suite
K173290 · MOS
Mr Instruments, Inc.
Radiology · 43d
Cleared Nov 15, 2017
jFit Surgical Planner
K173329 · LLZ
Jointvue, LLC
Radiology · 23d
Cleared Nov 07, 2017
UltraVision 2 Diagnostic Ultrasound System
K173265 · IYN
Winprobe Corporation
Radiology · 27d
Cleared Oct 31, 2017
Rapid HB, Rapid LB, Rapid MB
K173318 · ELW
3M Deutschland GmbH
Dental · 11d
Cleared Oct 30, 2017
Stethee Pro
K172296 · DQD
M3Dicine Pty , Ltd.
Cardiovascular · 91d
Cleared Oct 27, 2017
Biim Diagnostic Ultrasound System
K173138 · IYO
Biim Ultrasound AS
Radiology · 28d
Cleared Oct 18, 2017
ECG SENTINEL System
K172801 · DXH
Cardiomedix, Inc.
Cardiovascular · 30d
Cleared Oct 13, 2017
Freemie Independence, Freemie Liberty
K172772 · HGX
Dao Health
Obstetrics & Gynecology · 29d
Cleared Oct 04, 2017
Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound...
K172607 · IYN
Philips Health Care
Radiology · 35d