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
dilator, vessel, surgical
Product Code
DWP
Regulation Number
870.4475
Device Class
2
Premarket Reviews
Manufacturer
Decision
FEHLING SURGICAL INSTRUMENTS, INC.
SUBSTANTIALLY EQUIVALENT
1
FETZER MEDICAL GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
GEOMED MEDIZIN-TECHNIK GMBH & CO.
SUBSTANTIALLY EQUIVALENT
1
INSTRUMED INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
SYNOVIS LIFE TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
10
10
2015
25
25
2016
18
18
2017
34
34
2018
29
31
2019
5
5
2020
4
4
2021
2
2
2022
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Contamination with Chemical or Other Material
111
113
Break
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Particulates
2
2
Packaging Problem
2
2
Product Quality Problem
2
2
Unsealed Device Packaging
2
2
Device Operates Differently Than Expected
2
2
Material Twisted/Bent
1
1
Detachment of Device or Device Component
1
1
Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
104
104
No Known Impact Or Consequence To Patient
12
14
No Consequences Or Impact To Patient
6
6
No Clinical Signs, Symptoms or Conditions
3
3
Injury
2
2
No Information
1
1
Atherosclerosis
1
1
Vascular Dissection
1
1
Tissue Damage
1
1
Erosion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Jan-05-2024
-
-