• 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
11 to 20 of 500 Results *
Decision Date To: 05/21/2019
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]
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
z-800 volumetric infusion pump ZYNO MEDICAL LLC K071545 10/31/2007
nexwave combo muscle stimulator system ZYNEX MEDICAL, INC. K111279 09/20/2011
cardiac monitor 1500 Zynex Medical, Inc. K191697 02/21/2020
inwave ZYNEX MEDICAL, INC. K121820 08/24/2012
zynergy z4 transvenous bipolar pacing catheter, model 04-x-02-3-10-3 ZYNERGY CARDIOVASCULAR, INC. K002687 11/09/2000
zynergy z5000 electrophysiology catheter with z9000 accessory cable ZYNERGY CARDIO VASULAR (ZCV), INC. K011847 07/13/2001
dna/rna shield collection tube Zymo Research K202641 12/14/2020
virastat fitc-labeled anti-influenza a and b monoclonal antibodies ZYMETX, INC. K984596 03/04/1999
zstatflu test for influenza types a and b viruses ZYMETX, INC. K982429 08/25/1998
virazyme culture confirmation screen for influenza and parainfluenza viruses ZYMETX, INC. K950838 06/17/1996

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