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TPLC
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Device
injector and syringe, angiographic
Regulation Description
Angiographic injector and syringe.
Product Code
DXT
Regulation Number
870.1650
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACIST MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
NEMOTO KYORINDO CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NINGBO DIZEGENS MEDICAL SCIENCE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PRECISION MEDICAL PLASTICS LTD.
SUBSTANTIALLY EQUIVALENT
1
SHANDONG INT MEDICAL INSTRUMENTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN BOON MEDICAL SUPPLY CO., LTD
SUBSTANTIALLY EQUIVALENT
2
SHENZHEN BOON MEDICAL SUPPLY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
YOUWO (GUANGZHOU) MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
93
93
2021
132
132
2022
111
114
2023
117
117
2024
118
118
2025
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
188
188
Insufficient Information
33
33
Manufacturing, Packaging or Shipping Problem
32
32
Break
29
29
Detachment of Device or Device Component
18
18
Activation Problem
17
17
Air/Gas in Device
13
13
Fluid/Blood Leak
13
16
Defective Device
11
11
Inflation Problem
10
10
Contamination /Decontamination Problem
10
10
Gas/Air Leak
8
8
Mechanical Problem
7
7
Leak/Splash
7
7
Use of Device Problem
7
7
Output Problem
7
7
Therapeutic or Diagnostic Output Failure
6
6
Separation Failure
4
4
Self-Activation or Keying
4
4
Defective Component
4
4
No Apparent Adverse Event
4
4
Unsealed Device Packaging
3
3
Disconnection
3
3
Physical Resistance/Sticking
3
3
Inaccurate Delivery
3
3
Material Separation
3
3
Component Missing
3
3
Product Quality Problem
3
3
Deflation Problem
3
3
Pressure Problem
3
3
Appropriate Term/Code Not Available
3
3
Improper or Incorrect Procedure or Method
3
3
Unexpected Therapeutic Results
3
3
Connection Problem
2
2
Protective Measures Problem
2
2
Improper Flow or Infusion
2
2
Device Contaminated During Manufacture or Shipping
2
2
Device Displays Incorrect Message
2
2
Unexpected Shutdown
2
2
Display or Visual Feedback Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Entrapment of Device
2
2
Fire
2
2
Material Puncture/Hole
2
2
Material Integrity Problem
2
2
Loose or Intermittent Connection
2
2
Unintended Electrical Shock
2
2
Premature Activation
2
2
Contamination
2
2
Explosion
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
251
254
Air Embolism
137
137
Insufficient Information
59
59
Cardiac Arrest
32
32
Extravasation
22
22
No Patient Involvement
18
18
No Known Impact Or Consequence To Patient
17
17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Infiltration into Tissue
8
8
Low Blood Pressure/ Hypotension
7
7
Vascular Dissection
7
7
Respiratory Failure
7
7
Respiratory Arrest
6
6
Embolism/Embolus
6
6
Chest Pain
5
5
Chemical Exposure
4
4
No Consequences Or Impact To Patient
3
3
Death
3
3
Unspecified Tissue Injury
3
3
Electric Shock
3
3
Ventricular Fibrillation
2
2
Diaphoresis
2
2
Aneurysm
2
2
Arrhythmia
2
2
Ischemia Stroke
2
2
Myocardial Infarction
2
2
Rupture
1
1
Ischemic Heart Disease
1
1
Angina
1
1
Swelling/ Edema
1
1
Cough
1
1
Chills
1
1
Injury
1
1
Great Vessel Perforation
1
1
Underdose
1
1
Malaise
1
1
Ventilator Dependent
1
1
Hemorrhage/Bleeding
1
1
Perforation
1
1
Hypersensitivity/Allergic reaction
1
1
Pain
1
1
Overdose
1
1
Ischemia
1
1
Dyspnea
1
1
Eye Injury
1
1
Diminished Pulse Pressure
1
1
Vasoconstriction
1
1
Renal Impairment
1
1
Non specific EKG/ECG Changes
1
1
Stroke/CVA
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
B. Braun Medical, Inc.
II
Nov-03-2023
2
Bayer Medical Care, Inc.
II
Nov-03-2021
3
Bayer Medical Care, Inc.
II
Nov-23-2020
4
LeMaitre Vascular, Inc.
II
May-04-2021
5
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
6
Merit Medical Systems, Inc.
II
Oct-11-2024
7
Merit Medical Systems, Inc.
II
Oct-11-2024
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