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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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 64 64
Product Quality Problem 3 3
Inadequate Instructions for Non-Healthcare Professional 1 1
Mechanical Problem 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Appropriate Term/Code Not Available 1 1

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