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
-
21 to 30 of 499 Results
 < 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 > 
 
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]
disposable endoscope valves system Changzhou Endoclean Medical Device Co., Ltd. k232244 11/29/2023
nim standard reinforced emg endotracheal tube; contact reinforced emg endotracheal tube Medtronic Xomed, Inc. k230320 10/26/2023
axoguard ha+ nerve protector (agha12); axoguard ha+ nerve protector (agha22); axoguard ha+ nerve protector (agha24); axoguard ha+ nerve protector (agha36); axoguard ha+ nerve protector (agha48) Axogen Corporation k231708 10/12/2023
intellivue patient monitor mx400 (866060), intellivue patient monitor mx450 (866062), intellivue patient monitor mx500 (866064), intellivue patient monitor mx550 (866066) Philips Medizin Systeme Boeblingen GmbH k223574 08/22/2023
brainlab elements image fusion, contouring (4.5);image fusion (4.5);fibertracking (2.0);bold mri mapping (1.0);image fusion angio (1.0) Brainlab AG k223106 07/14/2023
acuity 100™ (hexafocon a) with tangible™ hydra-peg®, tyro™-97 (hofocon a) with tangible™ hydra-peg® rigid gas permeable contact lens Acuity Polymers, Inc. k230965 06/16/2023
transcutaneous electrical nerve stimulator, model: ktr-4031, ktr-4032, ktr-4012, ktr-4015, ktr-4029, ktr-4027, ktr-4026, ktr-4021, ktr-4034, ktr-4036, ktr-4037, ktr-4039 Shenzhen Kentro Medical Electronics Co., Ltd. k222870 05/10/2023
intense pulsed light treatment system Shangdong Huamei Technology Co., Ltd. k230816 04/21/2023
subdural electrode, strip/intraoperative strip, grid/intraoperative grid, multi-strip and split grid, intraoperative mapping grid Spes Medica Srl k211954 11/10/2022
ipl hair removal device, model(s): kca423, kca437, kca439 Hunan Guangye Biotechnology Co., Ltd. k222432 10/11/2022

-
-