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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device retractor, self-retaining, for neurosurgery
Regulation Description Self-retaining retractor for neurosurgery.
Product CodeGZT
Regulation Number 882.4800
Device Class 2


Premarket Reviews
ManufacturerDecision
FETZER MEDICAL GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
GEISTER MEDIZINTECHN
  SUBSTANTIALLY EQUIVALENT 1
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
NICO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TEDAN SURGICAL INNOVATIONS LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Mechanical Problem 2
Retraction Problem 1
Device Slipped 1
Device Damaged Prior to Use 1
Defective Component 1
Solder Joint Fracture 1
Manufacturing, Packaging or Shipping Problem 1
Material Deformation 1
Material Integrity Problem 1
Adverse Event Without Identified Device or Use Problem 1
Handpiece 1
Appropriate Term/Code Not Available 1
Crack 1
Total Device Problems 14

Recalls
Manufacturer Recall Class Date Posted
1 Nico Corp. II Aug-14-2018

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