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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device blade, scalpel
Regulation Description Manual surgical instrument for general use.
Product CodeGES
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN SAFETY
  SUBSTANTIALLY EQUIVALENT 2
ANCHOR PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1
NIRAJ INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 1
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 11
Fracture 4
Tear, rip or hole in device packaging 3
No code available 3
Device handling issue 2
Out-of-box failure 2
Manufacturing or shipping issue associated with device 2
No Known Device Problem 2
Dull 2
Detachment of device component 2
Defective item 2
Device operates differently than expected 2
Human-Device Interface Issue 1
Inadequate user interface 1
Detachment of device or device component 1
No display or display failure 1
Failure to cut 1
Material fragmentation 1
Loose or intermittent connection 1
Delivered as unsterile product 1
Product quality issue 1
Inappropriate shock 1
Device inoperable 1
Use of Device Issue 1
Component missing 1
No Information 1
Material integrity issue 1
Total Device Problems 52

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 2 0 0 1 0 0 0 1
Class III 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aspen Surgical Puerto Rico Corp. II Sep-08-2016
2 Becton Dickinson & Company III Oct-02-2007
3 Merit Medical Systems, Inc. II Dec-14-2009
4 Miltex, Inc. II Feb-20-2009
5 Miltex, Inc. II Apr-21-2007
6 Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. II Nov-05-2012

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