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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 system, delivery, allergen and vaccine
Product CodeLDH
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ALLERGY & APPLICATOR DEPOT, LLC
  SUBSTANTIALLY EQUIVALENT 1
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDSCIENCE SCIENCE RESEARCH GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROCARE INDUSTRIAL CO., LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SMART PRACTICE
  SUBSTANTIALLY EQUIVALENT 1
SMARTPRACTICE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Fracture 1 1
Unstable 1 1
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2 2
Skin Disorders 1 1
Bone Fracture(s) 1 1
High Blood Pressure/ Hypertension 1 1
Rash 1 1
Tachycardia 1 1
Burning Sensation 1 1
Dizziness 1 1
Injury 1 1
Sore Throat 1 1
Numbness 1 1
Shaking/Tremors 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Allergy Laboratories, Inc. II Sep-12-2016
2 Medscience Inc II May-31-2016
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