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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
suture, nonabsorbable, steel, monofilament and multifilament, sterile
Regulation Description
Stainless steel suture.
Product Code
GAQ
Regulation Number
878.4495
Device Class
2
Premarket Reviews
Manufacturer
Decision
CONEXTIONS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
FOOSIN MEDICAL SUPPLIES INC., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
52
52
2021
39
39
2022
70
70
2023
100
100
2024
176
176
2025
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
196
196
Break
153
153
Detachment of Device or Device Component
52
52
Adverse Event Without Identified Device or Use Problem
22
22
Material Twisted/Bent
11
11
Defective Component
6
6
Dull, Blunt
5
5
Delivered as Unsterile Product
5
5
Product Quality Problem
4
4
Device Contaminated During Manufacture or Shipping
3
3
Appropriate Term/Code Not Available
2
2
Unclear Information
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Integrity Problem
2
2
Packaging Problem
2
2
Use of Device Problem
2
2
Corroded
1
1
Loose or Intermittent Connection
1
1
Migration
1
1
Component Missing
1
1
Material Frayed
1
1
Insufficient Information
1
1
Misfire
1
1
Noise, Audible
1
1
Disconnection
1
1
Unraveled Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
326
326
No Consequences Or Impact To Patient
32
32
Insufficient Information
29
29
Hemorrhage/Bleeding
23
23
Foreign Body In Patient
9
9
Tissue Breakdown
8
8
Wound Dehiscence
7
7
Bone Fracture(s)
6
6
Not Applicable
5
5
Pain
3
3
Local Reaction
3
3
Hypersensitivity/Allergic reaction
3
3
Unspecified Infection
3
3
Inflammation
3
3
Itching Sensation
2
2
Tissue Damage
2
2
Rupture
2
2
Unspecified Tissue Injury
2
2
Unintended Radiation Exposure
2
2
No Known Impact Or Consequence To Patient
2
2
Rash
1
1
Sepsis
1
1
Skin Irritation
1
1
Impaired Healing
1
1
Cardiac Arrest
1
1
Erythema
1
1
Muscle/Tendon Damage
1
1
Swelling/ Edema
1
1
Blood Loss
1
1
No Patient Involvement
1
1
Osteopenia/ Osteoporosis
1
1
No Information
1
1
No Code Available
1
1
Renal Impairment
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
-
-