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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device forceps, obstetrical
Regulation Description Obstetric forceps.
Product CodeHDA
Regulation Number 884.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 5
Detachment of device component 3
Failure to align 3
Difficult to open or close 2
Mechanical issue 1
Total Device Problems 14

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