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"
241–264 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 30, 2020
Wiygul Catheter
K202566 · EZD
Big Blue Biotech, Inc.
Gastroenterology & Urology · 26d
Cleared Sep 30, 2020
DigitalDiagnost C90
K202564 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 26d
Cleared Sep 30, 2020
Allura Vaginal Stent
K202542 · KXP
Pmt Corporation
Obstetrics & Gynecology · 28d
Cleared Sep 28, 2020
Eon Aligner
K202685 · NXC
Eon Dental Jordan, LLC
Dental · 13d
Cleared Sep 16, 2020
Butterfly iQ Ultrasound System
K202406 · IYN
Butterfly Network, Inc.
Radiology · 26d
Cleared Sep 02, 2020
EPIQ Series Diagnostic Ultrasound Systems
K202216 · IYN
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Aug 26, 2020
MindsEye Expandable Port
K202072 · GZT
Minnetronix Neuro, Inc.
Neurology · 30d
Cleared Aug 18, 2020
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
K202012 · KNW
Devicor Medical Products, Inc.
General & Plastic Surgery · 28d
Cleared Aug 07, 2020
MVP Aligner System
K193130 · NXC
Mvp Aligners, LLC
Dental · 269d
Cleared Aug 06, 2020
Anchor Dual Lumen Guidewire Catheter
K201076 · QJP
Aqure Medical, Inc.
Neurology · 106d
Cleared Jul 10, 2020
HD Steth
K201299 · DQD
Hd Medical, Inc.
Cardiovascular · 56d
Cleared Jul 02, 2020
Terason uSmart 3200T Plus Ultrasound System
K201633 · IYN
Teratech Corporation
Radiology · 16d
Cleared Jun 24, 2020
ACUSON Sequoia Diagnostic Ultrasound System
K201462 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Jun 23, 2020
VarseoSmile Crown plus
K201668 · EBF
Bego Bremer Goldschl?gerei Wilh....
Dental · 4d
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