• 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
-
71 to 80 of 500 Results *
Decision Date To: 05/21/2019
 < 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 > 
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]
colink plating system, fracture and correction system, rts implant system, neospan compression staple system In2Bones USA, LLC K190385 08/08/2019
itotal identity cruciate retaining knee replacement system Conformis, Inc. K190562 08/08/2019
revolution centrifugal blood pump SORIN GROUP ITALIA S.R.L. K190650 08/07/2019
7d surgical system 7D Surgical Inc. K183276 08/07/2019
accurate multi panel drug urine test cup Healstone Biotech Inc K191841 08/07/2019
bonalive granules BonAlive Biomaterials Ltd. K191274 08/07/2019
navigated pedicle access kit IZI Medical Products LLC K191012 08/07/2019
illumisite platform Covidien llc K191394 08/07/2019
elevation spine saber-c system Elevation Spine K190885 08/07/2019
peripheral intravascular lithotripsy (ivl) catheters, ivl generator and connector cable kit, ivl connector cable (replacement) Shockwave Medical, Inc. K191840 08/07/2019

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