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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, ph, stomach
Regulation Description Stomach pH electrode.
Product CodeFFT
Regulation Number 876.1400
Device Class 1


Premarket Reviews
ManufacturerDecision
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
GIVEN IMAGING
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR TECHNOLOGY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to deploy 1015
Other (for use when an appropriate device code cannot be identified) 612
Failure to Adhere or Bond 222
Handpiece break 123
Unknown (for use when the device problem is not known) 68
Failure to advance 65
Difficult to deploy 43
No Known Device Problem 30
Device operates differently than expected 24
Detachment of device or device component 11
Data Issue 7
Detachment of device component 7
Premature deployment 4
Connection issue 4
Invalid sensing 4
Device Issue 4
Failure to separate 3
Implant, removal of 3
Output issue 3
Incorrect or inadequate result 3
Improper or incorrect procedure or method 3
Calibration error 3
Loss of or failure to bond 3
Difficult to position 3
Explanted 3
Poor quality image 2
Break 2
Bent 2
Intermittent continuity 2
Trocar failure 2
Device, or device fragments remain in patient 2
Difficult to remove 2
Device, removal of (non-implant) 2
Malfunction 2
No Information 2
Incompatibility problem 1
Component missing 1
Device contamination with blood or blood product 1
Device or device fragments location unknown 1
Failure to disconnect 1
Malposition of device 1
Calibration issue 1
Positioning Issue 1
Power source issue 1
Replace 1
Suction issue 1
Material perforation 1
Reuse 1
Spring loading mechanism problem 1
Unexpected therapeutic results 1
Probe failure 1
Failure to transmit record 1
Device remains implanted 1
Air leak 1
No device output 1
Failure to power-up 1
Foreign material 1
No display or display failure 1
Total Device Problems 2313

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

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II May-06-2016
2 Medtronic Neuromodulation II May-07-2008

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