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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
37
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Handling Problem
103
103
Insufficient Information
54
54
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
15
15
Fitting Problem
9
9
Difficult to Open or Close
7
7
Loss of or Failure to Bond
7
7
Pressure Problem
6
6
Lack of Effect
6
6
Defective Device
6
6
Loose or Intermittent Connection
5
5
Break
5
5
Sharp Edges
5
5
Device Slipped
4
4
Off-Label Use
4
4
Contamination
4
4
Detachment of Device or Device Component
4
4
Device Issue
3
3
Mechanics Altered
3
3
Positioning Failure
3
3
Device Contamination With Biological Material
3
3
Inadequacy of Device Shape and/or Size
3
3
Material Integrity Problem
3
3
Defective Component
3
3
Device-Device Incompatibility
2
2
Separation Problem
2
2
Detachment Of Device Component
2
2
Failure to Cut
2
2
Device Contamination with Chemical or Other Material
2
2
Problem with Sterilization
2
2
Mechanical Problem
2
2
Failure to Obtain Sample
2
2
No Apparent Adverse Event
2
2
Unintended Movement
2
2
Scratched Material
2
2
Material Discolored
2
2
Material Fragmentation
2
2
Malposition of Device
1
1
Excess Flow or Over-Infusion
1
1
Structural Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Failure to Align
1
1
Incorrect Device Or Component Shipped
1
1
Therapeutic or Diagnostic Output Failure
1
1
Human Factors Issue
1
1
Difficult to Insert
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Edema
113
113
Hemorrhage/Bleeding
66
66
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)
16
16
Genital Bleeding
14
14
Blood Loss
13
13
No Clinical Signs, Symptoms or Conditions
11
11
Insufficient Information
8
8
Tissue Damage
8
8
No Consequences Or Impact To Patient
7
7
Toxemia
7
8
No Information
4
4
Skin Tears
4
4
Unspecified Infection
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Death
2
2
Failure to Anastomose
2
2
Physical Entrapment
2
2
Swelling/ Edema
2
2
Complaint, Ill-Defined
1
1
Wound Dehiscence
1
1
Adhesion(s)
1
1
Hematoma
1
1
Abrasion
1
1
Post Traumatic Wound Infection
1
1
Foreign Body In Patient
1
1
No Patient Involvement
1
1
Swelling
1
1
Discomfort
1
1
Unspecified Tissue Injury
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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