Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
81 to 90 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
 < 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 13 
 > 
Results per Page
New Search  
Export all 500 Records to ExcelExport to Excel | Download Files | More About 510(k)
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Applicant
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
510(K)
Number
Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
Decision
Date
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
nanozoomer s360md slide scanner system Hamamatsu Photonics K.K. K233027 12/22/2023
neumodx ct/ng assay 2.0 NeuMoDx Molecular, Inc. K230267 12/22/2023
vivachek link plus blood glucose monitoring system VivaChek Biotech (Hangzhou) Co., Ltd. K233058 12/22/2023
winged infusion set, safety winged infusion set, blood collection set, blood collection set with holder, safety blood collection set, safety blood collection set with holder, needle holder Jiangsu Kangbao Medical Equipment Co., Ltd K232881 12/22/2023
kaibili extended viraltrans Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. K231027 12/21/2023
sysmex xq-series (xq-320) automated hematology analyzer Sysmex America, Inc. K230887 12/21/2023
ark methotrexate ii assay ARK Diagnostics, Inc. K232017 12/20/2023
bd vacutainer® serum separator (sst™) blood collection tubes Becton Dickinson and Company K230855 12/20/2023
chemtrue® drug screen fentanyl/tramadol cup test, chemtrue® drug screen fentanyl/tramadol dip card test, chemtrue® multi-panel drug screen cup test, chemtrue® multi-panel drug screen dip card test Chemtron Biotech, Inc. K232736 12/20/2023
inessa system Triple Jump Israel Ltd. K230545 12/20/2023

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
-
-