• 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
1 to 10 of 500 Results *
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]
Sort by PMA Number [0-9]
Sort by PMA Number [9-0]
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
card guard personal electrocardiogram transmitter, model cg-6206/6306 CARD GUARD SCIENTIFIC SURVIVAL, LTD. k000225 02/11/2000
protege wheelchair OTTO BOCK ORTHOPEDIC INDUSTRY, INC. k000602 03/03/2000
sterltech water purifier STERLTECH, INC. k000941 04/06/2000
control plasma n DADE BEHRING, INC. k001256 05/24/2000
trepchek treponemal antibody eia PHOENIX BIOTECH CORP. k001552 10/19/2000
aaron 1250 high frequency electrosurgical generator, model a1250 AARON MEDICAL INDUSTRIES k001955 12/22/2000
jms apheresis needle set accordion type JMS CO., LTD. k002394 09/05/2001
curon control module electrosurgical generator and accessories, model s500-st CURON MEDICAL, INC. k002898 10/17/2000
bioteque vaginal dilator BIOTEQUE AMERICA, INC. k003380 01/29/2001

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