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"
289–312 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 26, 2019
NuVasive NuvaLine
K192435 · LLZ
Nu Vasive, Incorporated
Radiology · 21d
Cleared Sep 19, 2019
ProPerformance Recovery System
K192252 · IRP
Menlo Brands, LLC
Physical Medicine · 30d
Cleared Sep 18, 2019
InnoSight Diagnostic Ultrasound System
K192254 · IYN
Qisda Corporation
Radiology · 29d
Cleared Sep 06, 2019
Lumify Diagnostic Ultrasound System
K192226 · IYN
Philips Health Care
Radiology · 21d
Cleared Sep 05, 2019
3M Clarity Aligners
K192119 · NXC
3M Company
Dental · 30d
Cleared Aug 29, 2019
Clarius Ultrasound Scanner
K192107 · IYN
Clarius Mobile Health Corp.
Radiology · 24d
Cleared Aug 29, 2019
EvaQMax Smoke Evacuation System
K192035 · FYD
Bio Protech, Inc.
General Hospital · 30d
Cleared Aug 23, 2019
OSW Aligner System
K191990 · NXC
Osw Manufacturing, LLC
Dental · 29d
Cleared Aug 15, 2019
ACUSON P200 Diagnostic Ultrasound System
K191922 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Aug 14, 2019
Zurich Pressure Guidewire System Model 100
K190852 · DXO
Zurich Medical, Inc.
Cardiovascular · 134d
Cleared Jul 10, 2019
Vave Personal Ultrasound System
K191541 · IYO
Vave Health, Inc.
Radiology · 29d
Cleared Jun 21, 2019
FloPatch (FP110)
K191388 · DPW
Flosonics Medical (R/A 1929803...
Cardiovascular · 28d
Cleared May 30, 2019
FlexSeal Introducer Sheath with Hydrophilic Coating
K190628 · DYB
Freudenberg Medical Mis, Inc.
Cardiovascular · 79d
Cleared May 29, 2019
3M RelyX Pediatric Resin Modified Glass Ionomer Cement
K191122 · EMA
3M Espe Dental Products
Dental · 30d
Cleared May 28, 2019
Clearlink System Solution Set
K180739 · FPA
Baxter Healthcare Corporation
General Hospital · 432d
Cleared May 24, 2019
Envision ultrasound pad and cover
K190802 · ITX
Civco Medical Solutions
Radiology · 56d
Cleared May 22, 2019
Erbe ESU Model VIO 3 with Accessories
K190823 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 51d
Cleared May 10, 2019
ExactVu High Resolution Micro-Ultrasound System
K190995 · IYN
Exact Imaging, Inc.
Radiology · 24d
Cleared May 09, 2019
Magic Clear Aligners
K190948 · NXC
Voodoo Manufacturing, Inc.
Dental · 28d
Cleared May 06, 2019
BioCardia 8.5 F Avance Steerable lntroducer
K190941 · DYB
Biocardia, Inc.
Cardiovascular · 26d
Cleared Apr 30, 2019
TOTIM Patient Cushion Immobilization System
K190894 · IYE
Essebi Medical Srl
Radiology · 25d
Cleared Apr 12, 2019
Ascent Cardiorespiratory Diagnostic Software
K181912 · BTY
Medical Graphics Corporation
Anesthesiology · 269d
Cleared Apr 11, 2019
Eye Prime
K190786 · IYO
Ellex Medical Pty, Ltd.
Radiology · 15d
Cleared Mar 20, 2019
BD Nexiva Closed IV Catheter System
K183399 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 103d