• 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, internal
Product CodeEFQ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
A PLUS INTERNATIONAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 5
ALBA HEALTH
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 6
BIOSEAL
  SUBSTANTIALLY EQUIVALENT 3
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DUKAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
DYNAREX
  SUBSTANTIALLY EQUIVALENT 4
INVOTEC INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
KENDALL
  SUBSTANTIALLY EQUIVALENT 5
MEDICAL ACTION INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEROCEL
  SUBSTANTIALLY EQUIVALENT 1
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  1
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Material frayed 11
Material integrity issue 9
Material fragmentation 8
Device operates differently than expected 6
Break 5
Detachment of device component 5
Product quality issue 5
No Known Device Problem 5
Torn material 3
Material disintegration 2
Device expiration issue 2
Component missing 2
Incomplete or missing packaging 2
Failure to obtain samples 1
Decreased sensitivity 1
Detachment of device or device component 1
Nonstandard device or device component 1
Unsealed device packaging 1
Device, or device fragments remain in patient 1
Other (for use when an appropriate device code cannot be identified) 1
Invalid sensing 1
Packaging issue 1
Total Device Problems 74

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

Recalls
Manufacturer Recall Class Date Posted
1 American Surgical Company II May-26-2016
2 Customed, Inc II Sep-03-2015

-
-