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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search Show TPLC since Back To Search Results
Device incubator, neonatal
Regulation Description Neonatal incubator.
Product CodeFMZ
Regulation Number 880.5400
Device Class 2


Premarket Reviews
ManufacturerDecision
BISTOS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Contamination During Use 6
Appropriate Term/Code Not Available 4
Adverse Event Without Identified Device or Use Problem 2
Loss of or Failure to Bond 1
Use of Device Problem 1
Patient Device Interaction Problem 1
Mechanical Problem 1
Insufficient Information 1
Total Device Problems 17

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Nov-19-2018
2 Natus Medical Incorporated II Oct-07-2016
3 Natus Medical Incorporated II Apr-11-2016
4 Ohmeda Medical II Mar-20-2017

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