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"
169–192 of 1,198
Search insights Median review: 28d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 16, 2022
K Clear
K220726 · NXC
Kline Europe GmbH
Dental · 2d
Cleared Feb 25, 2022
Normatec 3
K220217 · IRP
NormaTec Industries, LP
Physical Medicine · 30d
Cleared Feb 20, 2022
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
K220232 · LZA
Megine Industries Sdn Bhd
General Hospital · 24d
Cleared Feb 17, 2022
TENS & PMS (Model: SM9126)
K220150 · NUH
Hong Qiangxing (Shenzhen) Electronics...
Neurology · 29d
Cleared Feb 17, 2022
Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab...
K213972 · DQK
Ge Healthcare Information...
Cardiovascular · 59d
Cleared Feb 08, 2022
AcQCross Qx Integrated Transseptal Dilator/Needle
K220047 · DYB
Acutus Medical, Inc.
Cardiovascular · 34d
Cleared Feb 04, 2022
Micro C Medical Imaging System, M01
K212654 · IZL
Oxos Medical, Inc.
Radiology · 165d
Cleared Feb 03, 2022
LifePath Remote Patient Monitoring Platform
K211822 · DRG
Elastic Care Incorporated
Cardiovascular · 234d
Cleared Feb 01, 2022
Permadyne
K220257 · ELW
3M Deutschland GmbH
Dental · 1d
Cleared Jan 28, 2022
QuikPass Catheter
K214106 · DQY
Traverse Vascular, Inc.
Cardiovascular · 30d
Cleared Jan 23, 2022
D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
K213970 · FXX
Danameco Medical Joint Stock Corporation
General Hospital · 34d
Cleared Jan 16, 2022
Kangbeier Surgical Mask (Model: KBR-1001)
K213920 · FXX
Xinxiang Kangbeier Medical Technology...
General Hospital · 32d
Cleared Jan 13, 2022
Stronghold Group Nitrile Examination Glove, Powder Free
K213859 · LZA
Stronghold Group, LLC
General Hospital · 34d
Cleared Dec 27, 2021
Sonosite PX Ultrasound System
K213763 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 26d
Cleared Dec 23, 2021
dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for...
K213766 · MOS
Invivo Corporation
Radiology · 22d
Cleared Dec 22, 2021
Solas OR
K213691 · MWP
Cirdan Imaging, Ltd.
Radiology · 29d
Cleared Dec 21, 2021
iCOquit® Smokerlyzer®
K211918 · CCJ
Bedfont Scientific, Ltd.
Toxicology · 183d
Cleared Dec 16, 2021
UltiCare Disposable Pen Needles
K213407 · FMI
Ultimed Incorporated
General Hospital · 58d
Cleared Nov 18, 2021
Savvy Mask - Level 3 Surgical Face Mask
K213406 · FXX
Texas Medplast, LLC
General Hospital · 30d
Cleared Nov 09, 2021
WHILL Model C2
K213383 · ITI
Whill, Inc.
Physical Medicine · 27d
Cleared Oct 29, 2021
ds Head 32ch 3.0T
K213351 · MOS
Invivo Corporation (Business Trade...
Radiology · 21d
Cleared Oct 25, 2021
Titan Manufacturing Bipolar Forceps
K213386 · GEI
Titan Manufacturing, Inc.
General & Plastic Surgery · 12d
Cleared Sep 30, 2021
Philips IntelliVue GuardianSoftware (Rev. E.0X)
K212208 · DXJ
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 77d
Cleared Sep 29, 2021
DR Safety Syringe, Sterile Hypodermic needle for Single use
K212226 · MEG
Zhuhai DR Medical Instruments Co., Ltd.
General Hospital · 75d