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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
needle, tumor localization
Product Code
MIJ
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
10
10
2019
7
7
2020
3
3
2021
4
4
2022
2
2
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
12
12
Migration
5
5
Break
4
4
Migration or Expulsion of Device
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Material Fragmentation
2
2
Use of Device Problem
1
1
Device Damaged by Another Device
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Foreign Body In Patient
9
9
No Code Available
9
9
No Known Impact Or Consequence To Patient
4
4
No Clinical Signs, Symptoms or Conditions
3
3
Insufficient Information
2
2
No Consequences Or Impact To Patient
2
2
No Patient Involvement
1
1
No Information
1
1
Hemorrhage/Bleeding
1
1
Itching Sensation
1
1
Pain
1
1
Perforation
1
1
Pneumothorax
1
1
Skin Burning Sensation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Somatex Medical Technologies GMBH
II
Mar-10-2021
-
-