• 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 *
Decision Date To: 11/29/2022
 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
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]
Applicant
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
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]
wireless/wired x-ray flat panel detectors Allengers Medical Systems Limited K223009 11/27/2022
dentcare aligners DentCare Dental Lab Pvt Ltd. K222918 11/25/2022
powder-free latex examination gloves Guangdong Kingfa Sci.&Tech. Co., Ltd. K222612 11/25/2022
vsi holomedicine ApoQlar GmbH K213215 11/25/2022
disposable automatically retractable safety syringes (with detachable needle) Shantou Wealy Medical Instrument CO.,Ltd. K222452 11/23/2022
echogo heart failure Ultromics Limited K222463 11/23/2022
glenoid reconstruction system Medacta International S.A. K213459 11/23/2022
closed system transfer device Shinva Ande Healthcare Apparatus Co., Ltd. K201460 11/23/2022
lde4 lancing device i-SENS, Inc. K222656 11/23/2022
medical protective mask (model: 8862, 8862a, 8862b, 8862c, 8862d, 8862e) Guangdong Golden Leaves Technology Development Co., LTD K223068 11/23/2022

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