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

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
151 to 160 of 416 results
Decision Date To: 06/07/2024
 < 
 11 
 12 
 13 
 14 
 15 
 16 
 17 
 18 
 19 
 20 
 > 
results per page
New Search
Download Files | More About De Novo
Device Name
sort by device name [a-z]
sort by device name [z-a]
Requester
sort by requester [a-z]
sort by requester [z-a]
De Novo
Number
sort by DeNovo number [0-9]
sort by DeNovo number [9-0]
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]
BioXmark Nanovi A/S DEN220017 12/23/2022
VERIGENE GRAM POSITIVE BLOOD CULTURE NUC NANOSPHERE, INC DEN120014 K113450 06/26/2012
MISHA Knee System Moximed, Inc. DEN220033 04/10/2023
MolecuLight i:X MolecuLight Inc. DEN180008 07/31/2018
MOERAE SURGICAL MARKING PEN MOERAE MATRIX, INC. DEN130004 12/18/2014
Symani Surgical System MMI North America, Inc. DEN230032 04/05/2024
Miris Human Milk Analyzer Miris AB DEN180007 12/21/2018
QMS Plazomicin Immunoassay Microgenics Corporation DEN180030 11/19/2018
CEDIA SIROLIMUS ASSAY MICROGENICS CORP. DEN040008 K034069 07/28/2004
Permaseal MICRO INTERVENTIONAL DEVICES, INC. DEN150029 07/27/2016
-
-