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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device splint, intranasal septal
Product CodeLYA
Regulation Number 874.4780
Device Class 1


Premarket Reviews
ManufacturerDecision
ARTHROCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOMED ENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHITOGEL LTD
  SUBSTANTIALLY EQUIVALENT 1
COGENT THERAPEUTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENTRIGUE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC
  SUBSTANTIALLY EQUIVALENT 1
HEMOSTASIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC XOMED
  SUBSTANTIALLY EQUIVALENT 1
POLYGANICS BV
  SUBSTANTIALLY EQUIVALENT 2
SINEXUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIWAY LLC
  SUBSTANTIALLY EQUIVALENT 2
SPIWAY, LLC
  SUBSTANTIALLY EQUIVALENT 2
STS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 28 28
2016 28 28
2017 10 10
2018 19 19
2019 5 5
2020 6 6
2021 19 19
2022 8 8
2023 17 17
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37 37
Device Operates Differently Than Expected 23 23
Material Integrity Problem 14 14
Packaging Problem 14 14
Insufficient Information 10 10
Patient-Device Incompatibility 8 8
Tear, Rip or Hole in Device Packaging 5 5
Device Contamination with Chemical or Other Material 4 4
Migration or Expulsion of Device 3 3
Appropriate Term/Code Not Available 3 3
Device Dislodged or Dislocated 3 3
Material Fragmentation 3 3
Use of Device Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Unexpected Therapeutic Results 2 2
Activation Failure 2 2
Contamination of Device Ingredient or Reagent 2 2
Residue After Decontamination 2 2
Device Emits Odor 2 2
Material Too Rigid or Stiff 2 2
Microbial Contamination of Device 2 2
Device Ingredient or Reagent Problem 2 2
Obstruction of Flow 1 1
Labelling, Instructions for Use or Training Problem 1 1
Material Discolored 1 1
Inadequacy of Device Shape and/or Size 1 1
Difficult to Insert 1 1
Contamination /Decontamination Problem 1 1
Difficult to Remove 1 1
Unsealed Device Packaging 1 1
Migration 1 1
Over-Sensing 1 1
Unintended Movement 1 1
Material Disintegration 1 1
Incomplete or Missing Packaging 1 1
Coagulation in Device or Device Ingredient 1 1
Melted 1 1
Nonstandard Device 1 1
Improper Chemical Reaction 1 1
Material Frayed 1 1
Component Falling 1 1
Biocompatibility 1 1
High Capture Threshold 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Headache 17 17
No Clinical Signs, Symptoms or Conditions 17 17
Pain 16 16
Unspecified Infection 12 12
Inflammation 10 10
Hemorrhage/Bleeding 8 8
No Code Available 8 8
No Patient Involvement 8 8
No Known Impact Or Consequence To Patient 8 8
Reaction 7 7
Swelling/ Edema 6 6
No Consequences Or Impact To Patient 5 5
Pneumonia 5 5
Complaint, Ill-Defined 4 4
Bacterial Infection 4 4
Post Traumatic Wound Infection 4 4
Low Oxygen Saturation 3 3
Respiratory Insufficiency 3 3
Nausea 3 3
Sepsis 3 3
Unspecified Tissue Injury 3 3
Adhesion(s) 3 3
Scarring 3 3
Injury 3 3
Seroma 3 3
Therapeutic Response, Decreased 2 2
Swelling 2 2
Foreign Body In Patient 2 2
Epistaxis 2 2
Post Operative Wound Infection 2 2
Staphylococcus Aureus 2 2
Blood Loss 2 2
Respiratory Distress 2 2
Confusion/ Disorientation 1 1
Fever 1 1
Irritation 1 1
Visual Disturbances 1 1
Cellulitis 1 1
Obstruction/Occlusion 1 1
Dyspnea 1 1
Fall 1 1
Perforation 1 1
Scar Tissue 1 1
Prolapse 1 1
Failure to Anastomose 1 1
Intraocular Infection 1 1
Hematoma 1 1
Cyst(s) 1 1
Nasal Obstruction 1 1
Host-Tissue Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GELITA MEDICAL GMBH II Sep-19-2022
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