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
clamp, circumcision
Regulation Description
Obstetric-gynecologic specialized manual instrument.
Product Code
HFX
Regulation Number
884.4530
Device Class
2
Premarket Reviews
Manufacturer
Decision
MEDLINE INDUSTRIES, INC
SUBSTANTIALLY EQUIVALENT
1
WEE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
22
22
2021
5
5
2022
3
3
2023
33
33
2024
121
121
2025
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Product Quality Problem
60
60
Appropriate Term/Code Not Available
22
22
Material Too Soft/Flexible
19
19
Insufficient Information
16
16
Flaked
9
9
Fitting Problem
8
8
Loss of or Failure to Bond
6
6
Pressure Problem
6
6
Lack of Effect
6
6
Defective Device
5
5
Adverse Event Without Identified Device or Use Problem
5
5
Contamination
4
4
Sharp Edges
4
4
Positioning Failure
3
3
Detachment of Device or Device Component
3
3
Material Integrity Problem
3
3
Mechanical Problem
3
3
Material Fragmentation
2
2
Loose or Intermittent Connection
2
2
Defective Component
2
2
Failure to Cut
2
2
Problem with Sterilization
2
2
Separation Problem
2
2
Material Discolored
2
2
Positioning Problem
1
1
Excess Flow or Over-Infusion
1
1
Structural Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Mechanics Altered
1
1
Fracture
1
1
Device Slipped
1
1
Failure to Obtain Sample
1
1
Contamination /Decontamination Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Use of Device Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
No Apparent Adverse Event
1
1
Unexpected Color
1
1
Therapeutic or Diagnostic Output Failure
1
1
Break
1
1
Difficult to Open or Close
1
1
Device Dislodged or Dislocated
1
1
Failure to Align
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
102
102
Hemorrhage/Bleeding
53
53
Genital Bleeding
19
19
Insufficient Information
13
13
Laceration(s)
7
7
Injury
7
7
Skin Tears
4
4
No Known Impact Or Consequence To Patient
3
3
Unspecified Tissue Injury
2
2
Swelling/ Edema
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Tissue Damage
2
2
No Code Available
2
2
Wound Dehiscence
1
1
Abrasion
1
1
Adhesion(s)
1
1
Hematoma
1
1
Foreign Body In Patient
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MEDLINE INDUSTRIES, LP - Northfield
II
Oct-18-2024
2
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-29-2023
3
MEDLINE INDUSTRIES, LP - Northfield
II
Apr-19-2023
-
-