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TPLC
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show TPLC since
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Device
splint, intranasal septal
Product Code
LYA
Regulation Number
874.4780
Device Class
1
Premarket Reviews
Manufacturer
Decision
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
Appropriate Term/Code Not Available
3
3
Device Dislodged or Dislocated
3
3
Migration or Expulsion of Device
3
3
Material Fragmentation
3
3
Use of Device Problem
3
3
Unexpected Therapeutic Results
2
2
Contamination of Device Ingredient or Reagent
2
2
Device Emits Odor
2
2
Activation Failure
2
2
Residue After Decontamination
2
2
Material Too Rigid or Stiff
2
2
Microbial Contamination of Device
2
2
Device Ingredient or Reagent Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Material Discolored
1
1
Obstruction of Flow
1
1
Difficult to Insert
1
1
Improper Chemical Reaction
1
1
Contamination /Decontamination Problem
1
1
Unintended Movement
1
1
Material Disintegration
1
1
Difficult to Remove
1
1
Inadequacy of Device Shape and/or Size
1
1
Unsealed Device Packaging
1
1
Incomplete or Missing Packaging
1
1
Material Frayed
1
1
Migration
1
1
Labelling, Instructions for Use or Training Problem
1
1
Over-Sensing
1
1
Nonstandard Device
1
1
Coagulation in Device or Device Ingredient
1
1
Melted
1
1
Component Falling
1
1
High Capture Threshold
1
1
Biocompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
17
17
Headache
17
17
Pain
16
16
Unspecified Infection
12
12
Inflammation
10
10
No Code Available
8
8
No Patient Involvement
8
8
Hemorrhage/Bleeding
8
8
No Known Impact Or Consequence To Patient
8
8
Reaction
7
7
Swelling/ Edema
6
6
Pneumonia
5
5
No Consequences Or Impact To Patient
5
5
Complaint, Ill-Defined
4
4
Bacterial Infection
4
4
Post Traumatic Wound Infection
4
4
Low Oxygen Saturation
3
3
Nausea
3
3
Sepsis
3
3
Respiratory Insufficiency
3
3
Injury
3
3
Adhesion(s)
3
3
Unspecified Tissue Injury
3
3
Scarring
3
3
Seroma
3
3
Swelling
2
2
Foreign Body In Patient
2
2
Therapeutic Response, Decreased
2
2
Epistaxis
2
2
Post Operative Wound Infection
2
2
Staphylococcus Aureus
2
2
Blood Loss
2
2
Respiratory Distress
2
2
Loss of Vision
1
1
Toxic Shock Syndrome
1
1
Deformity/ Disfigurement
1
1
Eye Pain
1
1
Loss of consciousness
1
1
Airway Obstruction
1
1
Increased Respiratory Rate
1
1
Anxiety
1
1
Host-Tissue Reaction
1
1
Failure to Anastomose
1
1
Granuloma
1
1
Device Embedded In Tissue or Plaque
1
1
Intraocular Infection
1
1
Nasal Obstruction
1
1
Fall
1
1
Prolapse
1
1
Scar Tissue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GELITA MEDICAL GMBH
II
Sep-19-2022
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