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
-
191 to 200 of 416 results
Decision Date To: 06/16/2024
 < 
 15 
 16 
 17 
 18 
 19 
 20 
 21 
 22 
 23 
 24 
 > 
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]
VasQ Laminate Medical Technologies Ltd. DEN220026 09/26/2023
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) KRONUS, INC. DEN150030 04/25/2016
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELI KRONUS MARKET DEVELOPMENT ASSOCIATES, IN DEN140001 08/20/2014
Klox Biophotonic LumiHeal System Klox Technlogies Inc. DEN200005 12/03/2021
PREVENA 125 and PREVENA PLUS 125 Therapy KCI USA, Inc. DEN180013 04/19/2019
KAVO DIAGNODENT KAVO AMERICA DEN990002 K983658 02/22/2000
Nautilus BrainPulse 1000 JAN MEDICAL, INC. DEN140040 08/01/2016
iotaSOFT Insertion System - Drive Unit, IotaMotion, Inc. DEN190055 10/01/2021
IOGYN SYSTEM IOGYN, INC. DEN130040 K132695 03/28/2014
INVOcell INVO BIOSCIENCE DEN150008 11/02/2015
-
-