• 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, hydrogel w/drug and/or biologic
Product CodeMGQ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ACRYMED, INC.
  1
  SUBSTANTIALLY EQUIVALENT 2
AEON ASTRON EUROPE B.V.
  SUBSTANTIALLY EQUIVALENT 1
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLLEGIUM PHARMACEUTICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
DERMA SCIENCES CANADA, INC.
  2
  SUBSTANTIALLY EQUIVALENT 2
DEROYAL
  1
  SUBSTANTIALLY EQUIVALENT 1
DPT LABORATORIES, LTD.
  1
  SUBSTANTIALLY EQUIVALENT 1
FERRIS MFG. CORP.
  SUBSTANTIALLY EQUIVALENT 2
HEMCON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  2
  SUBSTANTIALLY EQUIVALENT 2
MAXXIM MEDICAL
  1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDTRADE PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
MOLNLYCKE HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 2
NORTH AMERICAN STERILIZATION & PACKAGING CO.
  SUBSTANTIALLY EQUIVALENT 1
SINCLAIR PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 4
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPENCO
  SUBSTANTIALLY EQUIVALENT 1
SWISS
  1
XYLOS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Not Applicable 2
No Known Device Problem 1
Patient-device incompatibility 1
Total Device Problems 4

-
-