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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device counter, sponge, surgical
Regulation Description Surgical sponge scale.
Product CodeLWH
Regulation Number 880.2740
Device Class 1


Premarket Reviews
ManufacturerDecision
CLEARCOUNT MEDICAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
RF SURGICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SURGICOUNT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
False positive result 2
False reading from device non-compliance 1
Unable to obtain readings 1
Material separation 1
Unraveled material 1
Improper or incorrect procedure or method 1
Unknown (for use when the device problem is not known) 1
Defective item 1
Material integrity issue 1
No Known Device Problem 1
Output issue 1
Total Device Problems 12

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 Stryker Instruments Div. of Stryker Corporation II Apr-13-2016
2 Stryker Instruments Div. of Stryker Corporation II Jan-15-2015

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