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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 saliva, artificial
Product CodeLFD
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ELEVATE ORAL CARE
  SUBSTANTIALLY EQUIVALENT 1
EUSA PHARMA (UK) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GURUNANDA, LLC
  SUBSTANTIALLY EQUIVALENT 1
LACLEDE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXY2PLUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ROWPAR PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE PROCTER & GAMBLE COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 30 30
2022 15 15
2023 10 10
2024 14 14
2025 11 11
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 60 60
Product Quality Problem 2 2
Appropriate Device Problem Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 38 38
Choking 11 11
Insufficient Information 5 5
Cough 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Swelling/ Edema 3 3
Pain 3 3
Hypersensitivity/Allergic reaction 3 3
Nausea 2 2
Hemorrhage/Blood Loss/Bleeding 2 2
Burning Sensation 2 2
Dyspnea 2 2
Paresthesia 2 2
Salivary Hypersecretion 2 2
Erythema 1 1
Swelling 1 1
Hypoxia 1 1
Stomatitis 1 1
Bronchospasm 1 1
Foreign Body In Patient 1 1
Anaphylactoid / Anaphylaxis 1 1
Urticaria 1 1
Numbness 1 1
Convulsion/Seizure 1 1
Inadequate Pain Relief 1 1
Airway Obstruction 1 1
Blister 1 1
Unspecified Tissue Injury 1 1
Hypoesthesia 1 1
Sore Throat 1 1
Eye Infections 1 1
Reaction to Medicinal Component of Device 1 1
Erectile Dysfunction 1 1
Coma 1 1
Asthma 1 1
Ear Pain 1 1
Respiratory Failure 1 1
Hypervolemia 1 1
Unspecified Gastrointestinal Problem 1 1
Upper Respiratory Tract Irritation 1 1
Headache 1 1
Dry Mouth 1 1
Abnormal mucus discharge 1 1
Arrhythmia 1 1
Foreign Body Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 RECORDATI RARE DISEASES INC. II Jun-23-2025
2 Sunstar Americas, Inc. II Mar-05-2021
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