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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, electrocardiograph
Regulation Description Electrocardiograph electrode.
Product CodeDRX
Regulation Number 870.2360
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 7
AMBU INTERNATIONAL A/S
  SUBSTANTIALLY EQUIVALENT 5
ASPECT
  SUBSTANTIALLY EQUIVALENT 1
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
AXELGAARD MFG
  SUBSTANTIALLY EQUIVALENT 1
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIO-DETEK, INC.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
CAMBRIDGE HEART, INC.
  SUBSTANTIALLY EQUIVALENT 2
COMMWELL LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 7
D.O. WEAVER
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
FERRIS MFG. CORP.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 5
INOVISE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
KATECHO, INC.
  SUBSTANTIALLY EQUIVALENT 2
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
LEONHARD LANG GMBH
  SUBSTANTIALLY EQUIVALENT 8
MAERSK MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 5
MEDICOTEST A/S
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 6
MINNESOTA MINING AND MFG. CO.
  SUBSTANTIALLY EQUIVALENT 1
MONEBO TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOTECH PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORBITAL RESEARCH INC.
  SUBSTANTIALLY EQUIVALENT 1
PHYSIO-CONTROL, INC.
  SUBSTANTIALLY EQUIVALENT 5
S & W MEDICO TEKNIK
  SUBSTANTIALLY EQUIVALENT 7
SUZUKEN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TEXTRONICS, INC
  SUBSTANTIALLY EQUIVALENT 1
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 1
VERMONT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
VITAL SIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Information 40
Not Applicable 14
Unknown (for use when the device problem is not known) 9
No display or display failure 7
No Known Device Problem 7
Sensitivity 3
Electrode contact(s), problem with 3
Burn of device or device component 2
Gel leak 2
Device displays error message 2
Spark 1
Device, removal of (non-implant) 1
Wrinkled 1
Device operates differently than expected 1
Gas leak 1
Failure to deliver 1
Difficult or delayed activation 1
Physical resistance 1
Grounding malfunction 1
Leak 1
Melted 1
Output, low 1
Failure to analyze rhythm 1
Detachment of device component 1
Displacement 1
Fluid leak 1
Failure to read input signal 1
Other (for use when an appropriate device code cannot be identified) 1
Failure to Adhere or Bond 1
No code available 1
Total Device Problems 109

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

Recalls
Manufacturer Recall Class Date Posted
1 3M Company / Medical Division II Sep-07-2010
2 Cambridge Heart, Inc. II Jun-07-2010
3 ConMed Corporation II Mar-02-2011
4 ConvaTec II Apr-22-2010
5 Leonhard Lang Medizintechnik GmbH II Nov-18-2015
6 Leonhard Lang Medizintechnik GmbH II Mar-28-2015

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