• 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 tourniquet, pneumatic
Regulation Description Pneumatic tourniquet.
Product CodeKCY
Regulation Number 878.5910
Device Class 1


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 5
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Inflation issue 6
Pressure issue 5
Break 3
Device operates differently than expected 2
Material deformation 2
Material torqued 2
Decrease in pressure 2
Material rigid or stiff 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Dissatisfaction 1
Device displays error message 1
Leak 1
Air leak 1
Battery failure 1
No Known Device Problem 1
Item contaminated during manufacturing or shipping 1
No Information 1
Total Device Problems 36

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 1 2 0 1 1 0 1 3 1
Class III 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ascent Healthcare Solutions, Inc. II Sep-19-2008
2 STERILMED, INC. II Dec-10-2015
3 STERILMED, INC. II Sep-28-2015
4 Sterilmed Inc II Jan-13-2009
5 Stryker Instruments Div. of Stryker Corporation II Jan-06-2014
6 Stryker Instruments Div. of Stryker Corporation III Sep-21-2011
7 Stryker Instruments Div. of Stryker Corporation II Jan-18-2011
8 Stryker Sustainability Solutions II Jan-12-2016
9 Virtus, Inc. II Jan-23-2009
10 Zimmer Surgical Inc II Aug-06-2015
11 Zimmer, Inc. II Nov-15-2012

-
-