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

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
121 to 130 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
 < 
 8 
 9 
 10 
 11 
 12 
 13 
 14 
 15 
 16 
 17 
 > 
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]
t:slim x2 insulin pump with interoperable technology Tandem Diabetes Care, Inc. K232380 11/03/2023
biosievetm multi-drug urine test panel; biosievetm multi-drug urine test panel rx VivaChek Biotech (Hangzhou) Co., Ltd K233062 11/02/2023
sensititre 20-24 hour haemophilus influenzaelstreptococcus pneumoniae mic or breakpoint susceptibility system with ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml Thermo Fisher Scientific K232310 10/31/2023
i-stat cg8+ cartridge with the i-stat 1 system Abbott Point of Care Inc K230285 10/27/2023
i-stat cg8+ cartridge with the i-stat 1 system Abbott Point of Care Inc. K230275 10/27/2023
i-stat cg8+ cartridge with the i-stat 1 system Abbott Point of Care Inc. K230300 10/27/2023
liaison vzv igg ht, liaison control vzv igg ht DiaSorin Inc. K231214 10/27/2023
safety butterfly type blood collection needle, butterfly type blood collection needle, pen type blood collection needle, safety pen Jiangsu Rongye Technology Co., Ltd. K213146 10/27/2023
alltest fentanyl urine test cassette Hangzhou AllTest Biotech Co.,Ltd K233417 10/26/2023
vitek 2 ast-streptococcus penicillin (<=0.06 - =>8 µg/ml), vitek 2 streptococcus penicillin (<=0.06 - >=8 µg/ml), vitek 2 streptococcus penicillin bioMerieux, Inc K232201 10/23/2023

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