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"
265–288 of 484
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
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