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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 dilator, cervical, synthetic, osmotic
Definition Cervical softening and dilation
Product CodePKN
Regulation Number 884.4260
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDICEM TECHNOLOGY S.R.O.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pelvic Inflammatory Disease 1 1
Uterine Perforation 1 1
Rupture 1 1
Foreign Body In Patient 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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