• 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 dressing, wound and burn, occlusive
Product CodeMGP
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
3M COMPANY
  1
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 2
BUSSE HOSPITAL DISPOSABLES, INC.
  1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
DERMA SCIENCES CANADA, INC.
  SUBSTANTIALLY EQUIVALENT 5
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
DUKAL CORP.
  1
ETHICON
  SUBSTANTIALLY EQUIVALENT 2
EURO-MED
  SUBSTANTIALLY EQUIVALENT 2
FIDIA FARMACEUTICI SPA
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  1
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 3
KENDALL
  1
  SUBSTANTIALLY EQUIVALENT 3
MOLNLYCKE HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 2
NORTH AMERICAN STERILIZATION & PACKAGING CO.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  1

Device Problems
No Information 3
No Known Device Problem 2
Delivered as unsterile product 1
Other (for use when an appropriate device code cannot be identified) 1
Tear, rip or hole in device packaging 1
Human-Device Interface Issue 1
Total Device Problems 9

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 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Hartmann USA, Inc III Apr-01-2011

-
-