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TPLC
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show TPLC since
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2024
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Device
clamp, circumcision
Product Code
HFX
Regulation Number
884.4530
Device Class
2
Premarket Reviews
Manufacturer
Decision
CIRC MEDTECH
SUBSTANTIALLY EQUIVALENT
1
MEDICFIT TECHNOLOGY SDN BHD
SUBSTANTIALLY EQUIVALENT
1
MEDICON, E.G.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC
SUBSTANTIALLY EQUIVALENT
1
NOVADIEN HEALTHCARE
SUBSTANTIALLY EQUIVALENT
1
WEE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
WUHU SNNA MEDICAL TREATMENT APPLIANCE TECHNOLOGY C
SUBSTANTIALLY EQUIVALENT
1
WUHU SNNDA MEDICAL TREATMENT APPLIANCE TECHNOLOGY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
20
20
2015
21
21
2016
147
147
2017
24
24
2018
13
13
2019
11
11
2020
22
22
2021
5
5
2022
3
3
2023
33
33
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Handling Problem
103
103
Insufficient Information
51
51
Device Dislodged or Dislocated
49
49
Adverse Event Without Identified Device or Use Problem
34
34
Device Operates Differently Than Expected
28
28
Use of Device Problem
25
25
Improper or Incorrect Procedure or Method
20
20
Appropriate Term/Code Not Available
12
12
Difficult to Open or Close
7
7
Pressure Problem
6
6
Defective Device
6
6
Break
5
5
Loose or Intermittent Connection
5
5
Off-Label Use
4
4
Contamination
4
4
Detachment of Device or Device Component
4
4
Device Slipped
4
4
Defective Component
3
3
Device Issue
3
3
Device Contamination With Biological Material
3
3
Positioning Failure
3
3
Material Integrity Problem
3
3
Mechanics Altered
3
3
Sharp Edges
3
3
Separation Problem
2
2
Scratched Material
2
2
Unintended Movement
2
2
No Apparent Adverse Event
2
2
Failure to Cut
2
2
Device-Device Incompatibility
2
2
Device Contamination with Chemical or Other Material
2
2
Material Discolored
2
2
Detachment Of Device Component
2
2
Material Fragmentation
2
2
Mechanical Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Failure to Obtain Sample
2
2
Problem with Sterilization
2
2
Fitting Problem
2
2
Structural Problem
1
1
Failure to Align
1
1
Failure to Form Staple
1
1
Malposition of Device
1
1
Contamination /Decontamination Problem
1
1
Device Markings/Labelling Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Loss of or Failure to Bond
1
1
Misassembled
1
1
Difficult to Remove
1
1
Self-Activation or Keying
1
1
Material Separation
1
1
Excess Flow or Over-Infusion
1
1
Difficult to Insert
1
1
Component Falling
1
1
Fail-Safe Design Failure
1
1
Human Factors Issue
1
1
Inadequate User Interface
1
1
Incorrect Device Or Component Shipped
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Packaging Problem
1
1
Positioning Problem
1
1
Unexpected Color
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Edema
113
113
Hemorrhage/Bleeding
45
45
Injury
28
28
No Known Impact Or Consequence To Patient
22
22
Patient Problem/Medical Problem
20
20
No Code Available
18
18
Laceration(s)
15
15
Blood Loss
13
13
Genital Bleeding
12
12
No Clinical Signs, Symptoms or Conditions
10
10
Tissue Damage
8
8
No Consequences Or Impact To Patient
7
7
Toxemia
7
8
Insufficient Information
7
7
No Information
4
4
Skin Tears
4
4
Unspecified Infection
3
3
Failure to Anastomose
2
2
Physical Entrapment
2
2
Death
2
2
Swelling/ Edema
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Patient Involvement
1
1
Foreign Body In Patient
1
1
Unspecified Tissue Injury
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Swelling
1
1
Post Traumatic Wound Infection
1
1
Wound Dehiscence
1
1
Abrasion
1
1
Adhesion(s)
1
1
Hematoma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Jan-05-2017
2
Centurion Medical Products Corporation
II
Oct-10-2019
3
DeRoyal Industries Inc
II
Mar-04-2014
4
Deroyal Industries, Inc. Lafollette
II
Sep-16-2011
5
Instrumed International, Inc.
II
Dec-16-2014
6
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-29-2023
7
MEDLINE INDUSTRIES, LP - Northfield
II
Apr-19-2023
8
Surgical Design Inc
II
May-06-2011
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