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
valvulotome
Regulation Description
External vein stripper.
Product Code
MGZ
Regulation Number
870.4885
Device Class
2
Premarket Reviews
Manufacturer
Decision
LEMAITRE VASCULAR
SUBSTANTIALLY EQUIVALENT
1
LIMFLOW, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
19
19
2020
6
6
2021
2
2
2022
13
13
2023
23
23
2024
3
3
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Retraction Problem
21
21
Difficult to Open or Close
19
19
Adverse Event Without Identified Device or Use Problem
9
9
Failure to Align
5
5
Material Twisted/Bent
2
2
Connection Problem
2
2
Material Deformation
2
2
Break
2
2
Material Separation
1
1
Positioning Problem
1
1
Flare or Flash
1
1
Difficult to Flush
1
1
Leak/Splash
1
1
Sharp Edges
1
1
Defective Component
1
1
Material Perforation
1
1
Device Markings/Labelling Problem
1
1
Fluid/Blood Leak
1
1
Failure to Cut
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
23
23
No Known Impact Or Consequence To Patient
13
13
Perforation of Vessels
13
13
Laceration(s)
5
5
Insufficient Information
4
4
No Patient Involvement
3
3
No Consequences Or Impact To Patient
3
3
Injury
1
1
Vascular Dissection
1
1
No Information
1
1
Blood Loss
1
1
Foreign Body In Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
LeMaitre Vascular, Inc.
II
Aug-28-2023
-
-