• 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 gauze/sponge,nonresorbable for external use
Regulation Description Nonresorbable gauze/sponge for external use.
Product CodeNAB
Regulation Number 878.4014
Device Class 1


Premarket Reviews
ManufacturerDecision
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  1
SPENCO
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Tear, rip or hole in device packaging 4
Material frayed 4
Failure to obtain samples 2
Flaked 2
Device or device fragments location unknown 1
No Information 1
Material deformation 1
Incomplete or missing packaging 1
Device abrasion from instrument or another object 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 18

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

Recalls
Manufacturer Recall Class Date Posted
1 Hartmann USA, Inc II Jun-22-2012
2 Revmedx Inc II Sep-11-2015

-
-