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
marker, radiographic, implantable
Regulation Description
Implantable clip.
Product Code
NEU
Regulation Number
878.4300
Device Class
2
Premarket Reviews
Manufacturer
Decision
C4 IMAGING LLC
SUBSTANTIALLY EQUIVALENT
1
DEVICOR MEDICAL PRODUCTS, INC
SUBSTANTIALLY EQUIVALENT
1
DEVICOR MEDICAL PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
5
ELUCENT MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ENDOMAGNETICS LTD
SUBSTANTIALLY EQUIVALENT
2
HEALTH BEACONS, INC.
SUBSTANTIALLY EQUIVALENT
1
INRAD INC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEM, INC.
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
MOLLI SURGICAL, INC
SUBSTANTIALLY EQUIVALENT
1
MOLLI SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
4
SOMATEX MEDICAL TECHNOLOGIES GMBH
SUBSTANTIALLY EQUIVALENT
1
SURGMARK GMBH
SUBSTANTIALLY EQUIVALENT
1
VIEW POINT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
45
45
2021
82
82
2022
100
100
2023
142
142
2024
247
247
2025
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
300
300
Migration
31
31
Use of Device Problem
27
27
Patient-Device Incompatibility
22
22
Detachment of Device or Device Component
17
17
Break
14
14
Positioning Failure
13
13
Device Markings/Labelling Problem
11
11
Difficult to Remove
11
11
Device Contamination with Chemical or Other Material
9
9
Separation Failure
8
8
Activation, Positioning or Separation Problem
7
7
Poor Quality Image
6
6
Entrapment of Device
6
6
Material Fragmentation
6
6
Incorrect Measurement
6
6
Migration or Expulsion of Device
6
6
Therapeutic or Diagnostic Output Failure
6
6
Mechanical Problem
6
6
Component Misassembled
5
5
Material Split, Cut or Torn
5
5
Device-Device Incompatibility
4
4
Activation Problem
4
4
Material Twisted/Bent
4
4
Insufficient Information
4
4
Patient Device Interaction Problem
4
4
Appropriate Term/Code Not Available
4
4
Output Problem
4
4
Improper or Incorrect Procedure or Method
3
3
Unable to Obtain Readings
3
3
Component or Accessory Incompatibility
3
3
Retraction Problem
3
3
Expiration Date Error
3
3
Difficult to Insert
3
3
Fracture
3
3
Component Missing
3
3
Device Slipped
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Material Discolored
2
2
Malposition of Device
2
2
Expulsion
2
2
Premature Activation
2
2
Failure to Advance
2
2
Audible Prompt/Feedback Problem
2
2
Unexpected Therapeutic Results
2
2
Difficult or Delayed Activation
2
2
Device Sensing Problem
2
2
Positioning Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Thermal Decomposition of Device
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Breast Discomfort/Pain
180
180
No Clinical Signs, Symptoms or Conditions
171
171
Erythema
62
62
Swelling/ Edema
53
53
Foreign Body In Patient
52
52
Sleep Dysfunction
47
47
Hypersensitivity/Allergic reaction
38
38
Pain
37
37
Bacterial Infection
37
37
Seroma
37
37
Hematoma
35
35
Itching Sensation
28
28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
23
23
Unspecified Infection
18
18
Necrosis
18
18
Failure of Implant
17
17
Insufficient Information
17
17
Deformity/ Disfigurement
17
17
Inflammation
15
15
Scar Tissue
15
15
Hemorrhage/Bleeding
15
15
Erosion
14
14
Bruise/Contusion
14
14
Burning Sensation
12
12
Implant Pain
12
12
Post Operative Wound Infection
10
10
Foreign Body Reaction
9
9
Post Traumatic Wound Infection
9
9
Rash
8
8
Anxiety
8
8
Abscess
7
7
Device Embedded In Tissue or Plaque
7
7
Impaired Healing
7
7
Discomfort
6
6
Fistula
6
6
Fluid Discharge
5
5
No Known Impact Or Consequence To Patient
5
5
Pancreatitis
5
5
Nodule
5
5
Wound Dehiscence
5
5
Unspecified Tissue Injury
4
4
Reaction
4
4
Abdominal Pain
4
4
Fever
4
4
Local Reaction
4
4
Hair Loss
4
4
Swollen Lymph Nodes/Glands
4
4
Purulent Discharge
4
4
Increased Sensitivity
3
3
Cancer
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Carbon Medical Technologies, Inc.
II
Jan-30-2023
2
Devicor Medical Products Inc
II
May-23-2022
3
Elucent Medical Inc
II
Jan-06-2025
4
Hologic, Inc
I
Nov-26-2024
5
Hologic, Inc
I
May-03-2024
6
Hologic, Inc
II
Sep-30-2022
-
-