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
-
41 to 50 of 500 Results *
 < 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 13 
 > 
results per page
New Searchexport reports to excelExport to Excel | HelpHelp
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Applicant
Sort by PMA Number [0-9]
Sort by PMA Number [9-0]
510(K)
Number
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
Decision
Date
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
axtiha stand-alone alif system Innovasis, Inc. k212967 10/15/2021
disposable hemoclip Beijing ZKSK Technology Co.,Ltd k213217 11/14/2022
serranator pta serration balloon catheter Cagent Vascular, LLC k213728 12/15/2021
tens&ems stimulator (model: kres100d, kres1010, kres1020, kres1080) Dongguan Bohuikang Technology Co.,Ltd k213788 05/06/2022
filmarray bcid2 control panel m416 Maine Molecular Quality Controls, Inc. k200010 04/02/2020
f&p evora nasal mask nasal a model (small, medium, large, wide), f&p evora nasal mask nasal fit pack/ sml (small/medium/large) a model, f&p evora nasal mask nasal sleep lab (small, medium, large, wide), f&p evora nasal mask nasal fit pack / sml (small/medium/large) sleep lab model Fisher & Paykel Healthcare Ltd. k200089 06/02/2020
plasmaflight ManaMed, Inc. k200351 08/05/2020
medical diode laser hair removal system Weifang Mingliang Electronics CO., LTD k200525 05/27/2020
clearblue® early digital pregnancy test SPD Swiss Precision Diagnostics GmbH k200913 08/13/2021
tisuthes e-ptfe surgical patch Shanghai Suokang Medical Implants Co., Ltd. k201153 06/13/2023

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
-
-