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
stripper, vein, external
Product Code
DWQ
Regulation Number
870.4885
Device Class
2
Premarket Reviews
Manufacturer
Decision
LEMAITRE VASCULAR INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
29
29
2020
5
5
2023
1
1
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Conduct
11
11
Electrical /Electronic Property Problem
7
7
No Device Output
3
3
Intermittent Loss of Power
2
2
Power Problem
1
1
Appropriate Term/Code Not Available
1
1
Material Split, Cut or Torn
1
1
Failure to Read Input Signal
1
1
Defective Component
1
1
Therapeutic or Diagnostic Output Failure
1
1
Defective Device
1
1
Overheating of Device
1
1
Loose or Intermittent Connection
1
1
Loss of Power
1
1
Mechanical Jam
1
1
Noise, Audible
1
1
Device Contamination with Body Fluid
1
1
Unintended Movement
1
1
Failure to Power Up
1
1
Mechanics Altered
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
23
23
No Patient Involvement
5
5
No Information
4
4
No Clinical Signs, Symptoms or Conditions
3
3
No Consequences Or Impact To Patient
2
2
-
-