Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
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
MOCHIDA PHARMACEUTICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
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
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
22
22
Migration
13
13
Appropriate Term/Code Not Available
10
10
Insufficient Information
8
8
Device Expiration Issue
6
6
Shelf Life Exceeded
6
6
Patient-Device Incompatibility
5
5
Device Operates Differently Than Expected
3
3
Device Appears to Trigger Rejection
3
3
Use of Device Problem
2
2
No Apparent Adverse Event
2
2
Improper or Incorrect Procedure or Method
2
2
Extrusion
1
1
Material Disintegration
1
1
Unintended Movement
1
1
Expiration Date Error
1
1
Patient Device Interaction Problem
1
1
Failure to Fold
1
1
Contamination
1
1
Device Handling Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Contamination with Chemical or Other Material
1
1
Peeled/Delaminated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Impaired Healing
14
14
No Known Impact Or Consequence To Patient
12
12
Swelling
12
12
Inflammation
8
8
No Clinical Signs, Symptoms or Conditions
6
6
Pain
6
6
Unspecified Infection
5
5
Numbness
5
5
No Consequences Or Impact To Patient
5
5
Post Operative Wound Infection
4
4
Peripheral Nervous Injury
4
4
Reaction
4
4
Hypersensitivity/Allergic reaction
3
3
Wound Dehiscence
3
3
Synovitis
3
3
Purulent Discharge
3
3
Seroma
3
3
Injury
3
3
Erythema
3
3
Bacterial Infection
3
3
Skin Infection
2
2
Nausea
2
2
Failure of Implant
2
2
No Code Available
2
2
Fever
2
2
Fluid Discharge
2
2
Swelling/ Edema
2
2
Granuloma
2
2
Tingling
1
1
Skin Irritation
1
1
Skin Inflammation/ Irritation
1
1
Adhesion(s)
1
1
Foreign Body Reaction
1
1
Staphylococcus Aureus
1
1
Post Traumatic Wound Infection
1
1
Irritation
1
1
Scar Tissue
1
1
Abscess
1
1
Host-Tissue Reaction
1
1
Fibrosis
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
-
-