Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device gauze/sponge, internal, x-ray detectable
Regulation Description Nonabsorbable gauze for internal use.
Product CodeGDY
Regulation Number 878.4450
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSEAL
  SUBSTANTIALLY EQUIVALENT 3
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ACTION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material frayed 124
Flaked 21
Material fragmentation 7
Detachment of device component 5
Material disintegration 5
Other (for use when an appropriate device code cannot be identified) 4
Detachment of device or device component 4
Material separation 3
Excessive Manipulation 2
Break 2
Component(s), broken 1
Fire 1
Reaction 1
Device or device fragments location unknown 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 182

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 0 2 0 1 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Jun-02-2010
2 International Medsurg Connection, Inc. II May-10-2012
3 Medline Industries Inc II Sep-20-2008
4 Stryker Instruments Div. of Stryker Corporation II Mar-15-2010

-
-