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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
ORALABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OXY2PLUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SUNBIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE PROCTER & GAMBLE COMPANY
  SUBSTANTIALLY EQUIVALENT 2
TRIUMPH PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 40 40
2020 34 34
2021 30 30
2022 15 15
2023 10 10
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 115 115
Product Quality Problem 9 9
Patient-Device Incompatibility 6 6
Improper or Incorrect Procedure or Method 3 3
Inadequate Instructions for Non-Healthcare Professional 1 1
No Apparent Adverse Event 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
No Code Available 23 23
Choking 20 20
Dyspnea 5 5
Stroke/CVA 4 4
Death 4 4
Burning Sensation 4 4
Reaction 4 4
Discomfort 3 3
Cataract 3 3
Swelling 3 3
Vomiting 3 3
Pain 3 3
Cough 3 3
Loss of consciousness 2 2
Myocardial Infarction 2 2
Nausea 2 2
Dysphagia/ Odynophagia 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 2 2
Anaphylactic Shock 2 2
Asthma 2 2
Sjogren's Syndrome 2 2
Seizures 2 2
Numbness 2 2
Tingling 2 2
Dysphasia 1 1
Stenosis 1 1
Urticaria 1 1
Anxiety 1 1
Coma 1 1
Complaint, Ill-Defined 1 1
Sore Throat 1 1
Sepsis 1 1
Weakness 1 1
Therapeutic Effects, Unexpected 1 1
Bacterial Infection 1 1
Apnea 1 1
Arrhythmia 1 1
Emotional Changes 1 1
Feeding Problem 1 1
Headache 1 1
Inflammation 1 1
Respiratory Distress 1 1
Sweating 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Dry Mouth 1 1
Salivary Hypersecretion 1 1
Reaction to Medicinal Component of Device 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Hypervolemia 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Cancer 1 1
Convulsion/Seizure 1 1
Paresthesia 1 1
Taste Disorder 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Sunstar Americas, Inc. II Mar-05-2021
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