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TPLC
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show TPLC since
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2024
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Device
cuff, nerve
Product Code
JXI
Regulation Number
882.5275
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALAFAIR BIOSCIENCES INC
SUBSTANTIALLY EQUIVALENT
2
AXOGEN CORPORATION
SUBSTANTIALLY EQUIVALENT
3
BIOCIRCUIT TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K233533
NerveTape
BIOCIRCUIT TECHNOLOGIES, INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
BIOM'UP SAS
SUBSTANTIALLY EQUIVALENT
1
CELESTRAY BIOTECH COMPANY, LLC.,
SUBSTANTIALLY EQUIVALENT
1
COLLAGEN MATRIX, INC.
SUBSTANTIALLY EQUIVALENT
2
COOK BIOTECH INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
INTEGRA LIFESCIENCES CORPORATION
SUBSTANTIALLY EQUIVALENT
2
MEDOVENT GMBH
SUBSTANTIALLY EQUIVALENT
2
MONARCH BIOIMPLANTS GMBH
SUBSTANTIALLY EQUIVALENT
1
POLYGANICS BV
SUBSTANTIALLY EQUIVALENT
1
POLYGANICS INNOVATIONS BV
SUBSTANTIALLY EQUIVALENT
1
RENERVE LTD
SUBSTANTIALLY EQUIVALENT
1
SALUMEDICA, L.L.C.
SUBSTANTIALLY EQUIVALENT
1
TOYOBO CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
5
5
2016
8
8
2017
9
9
2018
6
6
2019
10
10
2020
5
5
2021
3
3
2022
8
8
2023
15
15
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
21
21
Migration
13
13
Insufficient Information
8
8
Appropriate Term/Code Not Available
7
7
Device Expiration Issue
6
6
Shelf Life Exceeded
6
6
Patient-Device Incompatibility
5
5
Device Operates Differently Than Expected
3
3
Improper or Incorrect Procedure or Method
2
2
Device Appears to Trigger Rejection
2
2
No Apparent Adverse Event
2
2
Unintended Movement
1
1
Material Disintegration
1
1
Failure to Fold
1
1
Peeled/Delaminated
1
1
Expiration Date Error
1
1
Inadequacy of Device Shape and/or Size
1
1
Use of Device Problem
1
1
Extrusion
1
1
Device Contamination with Chemical or Other Material
1
1
Device Handling Problem
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Impaired Healing
13
13
Swelling
12
12
No Known Impact Or Consequence To Patient
12
12
Inflammation
8
8
Numbness
5
5
Unspecified Infection
5
5
No Consequences Or Impact To Patient
5
5
Reaction
4
4
Peripheral Nervous Injury
4
4
Post Operative Wound Infection
4
4
Pain
4
4
No Clinical Signs, Symptoms or Conditions
4
4
Hypersensitivity/Allergic reaction
3
3
Purulent Discharge
3
3
Erythema
3
3
Injury
3
3
Synovitis
3
3
Seroma
3
3
Fluid Discharge
2
2
Skin Infection
2
2
No Code Available
2
2
Fever
2
2
Wound Dehiscence
2
2
Failure of Implant
2
2
Bacterial Infection
2
2
Granuloma
2
2
Swelling/ Edema
2
2
Staphylococcus Aureus
1
1
Scar Tissue
1
1
Irritation
1
1
Nausea
1
1
Host-Tissue Reaction
1
1
Abscess
1
1
Adhesion(s)
1
1
Foreign Body Reaction
1
1
Skin Inflammation/ Irritation
1
1
Fibrosis
1
1
Skin Irritation
1
1
Tingling
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Apr-25-2023
2
Integra LifeSciences Corp.
III
Mar-11-2020
3
Integra LifeSciences Corporation
II
May-10-2013
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