• 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 computer, diagnostic, pre-programmed, single-function
Regulation Description Single-function, preprogrammed diagnostic computer.
Product CodeDXG
Regulation Number 870.1435
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K000664  VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONIT ...
  2.  K893392  CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER
  3.  K896930  CARDIAC OUTPUT COMPUTER, MODEL COM-3
CHEETAH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 10
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 6
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
INTEGRATED MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 1
MEDASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL DATA ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL GRAPHICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 3
OMEGA
  SUBSTANTIALLY EQUIVALENT 1
PULSION MEDICAL INC., USA
  SUBSTANTIALLY EQUIVALENT 3
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 1
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
WITT BIOMEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Incorrect or inadequate result 79
Smoking 17
Incorrect measurement 15
Measurements, inaccurate 6
Burn of device or device component 5
Unknown (for use when the device problem is not known) 5
Break 4
Low readings 3
Device remains activated 2
Cut in material 2
Use of Device Issue 2
False reading from device non-compliance 2
Fire 2
Fluid leak 1
Inflation issue 1
Circuit Failure 1
Coagulation in device or device ingredient 1
Contamination during use 1
Intermittent continuity 1
False device output 1
Unstable 1
Melted 1
Overheating of device or device component 1
Pyrogenic 1
Blood in tubing 1
Improper or incorrect procedure or method 1
Other (for use when an appropriate device code cannot be identified) 1
Incorrect or inadequate test results 1
Material perforation 1
Blood pooling 1
Spark 1
Device operates differently than expected 1
Improper device output 1
No Known Device Problem 1
Total Device Problems 165

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

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, Llc II Feb-02-2012
2 Edwards Lifesciences, Llc II Oct-28-2010
3 Edwards Lifesciences, Llc II Nov-24-2007
4 Hospira Inc II Nov-09-2009
5 Transonic Systems Inc II Apr-18-2013

-
-