• 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 bandage, liquid
Regulation Description Liquid bandage.
Product CodeKMF
Regulation Number 880.5090
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  1
  SUBSTANTIALLY EQUIVALENT 5
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
ACRYMED, INC.
  1
  SUBSTANTIALLY EQUIVALENT 1
ADRI/TECHNAM
  1
APLICARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AXIOM
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 1
  2
BIOCURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIO-MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  1
BUSSE HOSPITAL DISPOSABLES, INC.
  1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLOSURE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 5
CONTINENTAL MEDICAL LABORATORIES, INC.
  1
DERMA SCIENCES CANADA, INC.
  2
  SUBSTANTIALLY EQUIVALENT 3
DEROYAL
  1
DPT LABORATORIES, LTD.
  1
DYNAREX
  SUBSTANTIALLY EQUIVALENT 2
FERRIS MFG. CORP.
  SUBSTANTIALLY EQUIVALENT 2
  3
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
GLUSTITCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  1
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  4
  SUBSTANTIALLY EQUIVALENT 5
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 3
MARINE POLYMER TECHNOLOGIES, INC.
  1
  SUBSTANTIALLY EQUIVALENT 2
MEDAFOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRADE PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEROCEL
  SUBSTANTIALLY EQUIVALENT 1
  2
MOLNLYCKE HEALTH CARE
  1
NORTH AMERICAN STERILIZATION & PACKAGING CO.
  SUBSTANTIALLY EQUIVALENT 1
NOVABAY PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 1
PROCUREMENT TECHNOLOGY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPENCO
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  1
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 7
No Information 6
Use of Device Issue 3
Improper or incorrect procedure or method 1
Human-Device Interface Issue 1
Other (for use when an appropriate device code cannot be identified) 1
Inadequate user interface 1
Foreign material present in device 1
Total Device Problems 21

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

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Corp Skin Care Div II Apr-04-2007
2 Smith & Nephew Inc. II Jul-06-2011

-
-