• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device device,anastomotic,microvascular
Regulation Description Implantable clip.
Product CodeMVR
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 22
No Known Device Problem 9
Deployment issue 4
Dislodged or dislocated 1
Naturally worn 1
Failure to conduct 1
False positive result 1
Difficult to position 1
Failure to sense 1
Failure to advance 1
Failure to separate 1
Delivery system failure 1
Total Device Problems 44

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Synovis Micro Companies Alliance Inc II Aug-02-2008

-
-