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"
217–240 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 06, 2021
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
K201936 · KPE
Gilero, LLC
General Hospital · 297d
Cleared Apr 28, 2021
Plato 17 Microcatheter
K210601 · DQY
Scientia Vascular, LLC
Neurology · 58d
Cleared Apr 23, 2021
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
K211190 · NXC
3M Company, Unitek Orthodontic Products
Dental · 2d
Cleared Apr 06, 2021
AcQCross Qx Integrated Transseptal Dilator/Needle
K210685 · DYB
Acutus Medical, Inc.
Cardiovascular · 29d
Cleared Apr 01, 2021
ACUSON Redwood Diagnostic Ultrasound System
K210743 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Mar 30, 2021
Surgical Face Masks
K202708 · FXX
Intco Medical(Hk) Co., Ltd.
General Hospital · 195d
Cleared Mar 29, 2021
LumiCare Caries Diagnostic Rinse
K200601 · LFC
GreenMark Biomedical, Inc.
Dental · 385d
Cleared Mar 16, 2021
MIPLNI YK-244 Disposable Surgical Mask
K210487 · FXX
Hunan Yuankang Biological Technology...
General Hospital · 25d
Cleared Mar 05, 2021
Surgical Mask
K203425 · FXX
Bdc Dental Corporation , Ltd.
General Hospital · 105d
Cleared Mar 04, 2021
Surgical Face Mask
K210225 · FXX
Feng Chun Yuan Medical Equipment...
General Hospital · 35d
Cleared Mar 02, 2021
IFM Surgical Mask Model SM3
K202214 · FXX
Fssc, LLC
General Hospital · 208d
Cleared Mar 01, 2021
Recon Support Catheter
K203275 · DQY
C.R. Bard, Inc.
Cardiovascular · 115d
Cleared Feb 09, 2021
nPro Surgical Mask
K203265 · FXX
Np Medical, Inc.
General Hospital · 96d
Cleared Feb 05, 2021
Freudenberg Surgical Mask
K210063 · FXX
Freudenberg Performance Materials LP
General Hospital · 25d
Cleared Feb 04, 2021
BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set
K210174 · NGX
Bemer Int AG
Physical Medicine · 13d
Cleared Jan 26, 2021
VASOBand Vascular Compression Device
K203803 · DXC
Vasoinnovations, Inc.
Cardiovascular · 29d
Cleared Jan 12, 2021
Micro C Medical Imaging System, M01
K203658 · IZL
Oxos Medical, Inc.
Radiology · 28d
Cleared Jan 12, 2021
C Scope Visualization System
K203526 · HRX
Cit Ortho
Orthopedic · 41d
Cleared Dec 22, 2020
Rapid Reboot
K203552 · IRP
Rapid Reboot Recovery Products, LLC
Physical Medicine · 18d
Cleared Dec 04, 2020
Nucleus.io
K203249 · LLZ
Nucleushealth, LLC
Radiology · 30d
Cleared Dec 03, 2020
CombiDiagnost R90
K203087 · JAA
Philips Medical Systems Dmc GmbH
Radiology · 51d
Cleared Nov 25, 2020
The Multimodality Advanced Vessel Analysis
K203216 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 23d
Cleared Oct 29, 2020
CloudVue
K203058 · LLZ
International Medical Solutions, Inc.
Radiology · 21d
Cleared Oct 29, 2020
Female Luer Lock Cap
K200425 · FPA
Medsafety Solutions, LLC
General Hospital · 252d