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TPLC
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Device
injector and syringe, angiographic
Product Code
DXT
Regulation Number
870.1650
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACIST MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
3
BAYER MEDICAL CARE INC.
SUBSTANTIALLY EQUIVALENT
4
BAYER MEDICAL CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
COEUR, INC.
SUBSTANTIALLY EQUIVALENT
2
DEROYAL INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT - KIT
1
ECOMED SOLUTIONS, LLC
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
SUBSTANTIALLY EQUIVALENT - KIT
1
NEMOTO KYORINDO CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NINGBO DIZENGENS MEDICAL SCIENCE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OSPREY MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
OSPREY MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
7
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
SUBSTANTIALLY EQUIVALENT
2
SHENYANG MASTECH MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD
SUBSTANTIALLY EQUIVALENT
2
SHENZHEN BOON MEDICAL SUPPLY CO., LTD
SUBSTANTIALLY EQUIVALENT
2
SUNNY MEDICAL DEVICE (SHENZHEN) CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
UNION MEDICAL SHENZHEN CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
SUBSTANTIALLY EQUIVALENT
1
YOUWO (GUANGZHOU) MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
152
152
2017
128
128
2018
129
129
2019
121
121
2020
93
93
2021
132
132
2022
111
114
2023
117
117
2024
31
31
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
274
274
Device Contamination with Chemical or Other Material
67
67
Insufficient Information
55
55
Manufacturing, Packaging or Shipping Problem
52
52
Break
45
45
Air Leak
45
45
Detachment of Device or Device Component
37
37
Device Operates Differently Than Expected
36
36
Inflation Problem
26
26
Defective Device
22
22
Material Integrity Problem
22
22
Fluid/Blood Leak
20
23
Smoking
19
19
Use of Device Problem
19
19
Contamination /Decontamination Problem
19
19
Gas/Air Leak
18
18
Product Quality Problem
18
18
Leak/Splash
18
18
Improper or Incorrect Procedure or Method
17
17
Activation Problem
17
17
Mechanical Problem
12
12
Device Contaminated During Manufacture or Shipping
11
11
Device Displays Incorrect Message
10
10
Air/Gas in Device
10
10
Output Problem
8
8
Nonstandard Device
8
8
Particulates
8
8
Self-Activation or Keying
8
8
Material Disintegration
7
7
Therapeutic or Diagnostic Output Failure
7
7
Appropriate Term/Code Not Available
7
7
Device Dislodged or Dislocated
7
7
Patient-Device Incompatibility
6
6
Inaccurate Delivery
6
6
Crack
6
6
Deflation Problem
5
5
Thermal Decomposition of Device
5
5
Electrical /Electronic Property Problem
5
5
Disconnection
5
5
Failure to Deliver
5
5
Defective Component
5
5
Separation Failure
5
5
No Apparent Adverse Event
5
5
Noise, Audible
4
4
Connection Problem
4
4
Improper Flow or Infusion
4
4
Component Missing
4
4
Sparking
4
4
Unsealed Device Packaging
4
4
Failure to Power Up
4
4
Fire
4
4
Display or Visual Feedback Problem
4
4
Loose or Intermittent Connection
4
4
Excess Flow or Over-Infusion
3
3
No Display/Image
3
3
Entrapment of Device
3
3
Contamination
3
3
Device Alarm System
3
3
Detachment Of Device Component
3
3
Component Falling
3
3
Material Puncture/Hole
3
3
Material Separation
3
3
Unexpected Therapeutic Results
3
3
Device Inoperable
3
3
Communication or Transmission Problem
3
3
Physical Property Issue
3
3
Improper Device Output
3
3
Pressure Problem
3
3
Protective Measures Problem
3
3
Device Handling Problem
3
3
Physical Resistance/Sticking
3
3
Device Fell
2
2
Unintended Electrical Shock
2
2
Unexpected Shutdown
2
2
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
2
2
Material Twisted/Bent
2
2
Explosion
2
2
Material Split, Cut or Torn
2
2
Human-Device Interface Problem
2
2
Device Markings/Labelling Problem
2
2
Device Issue
2
2
Failure to Disconnect
2
2
Inappropriate/Inadequate Shock/Stimulation
2
2
Loss of Power
2
2
Sticking
2
2
Premature Activation
2
2
Device Difficult to Setup or Prepare
2
2
Device Emits Odor
2
2
Unintended System Motion
2
2
Bent
2
2
Backflow
2
2
Partial Blockage
2
2
Loss of or Failure to Bond
2
2
Application Program Problem: Dose Calculation Error
2
2
Fracture
2
2
Image Display Error/Artifact
1
1
Flushing Problem
1
1
Unintended Ejection
1
1
Flaked
1
1
Inaccurate Flow Rate
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Air Embolism
198
199
No Clinical Signs, Symptoms or Conditions
192
195
No Known Impact Or Consequence To Patient
170
170
No Patient Involvement
87
87
No Consequences Or Impact To Patient
64
64
Insufficient Information
52
52
Cardiac Arrest
48
48
Extravasation
43
43
Not Applicable
31
31
Death
28
28
No Information
22
22
Vascular Dissection
22
22
Low Blood Pressure/ Hypotension
14
14
No Code Available
13
13
Respiratory Failure
10
10
Patient Problem/Medical Problem
8
8
Embolism
8
8
Chest Pain
8
8
Pain
8
8
Ventricular Fibrillation
7
7
Infiltration into Tissue
7
7
Bradycardia
6
6
Chemical Exposure
6
6
Respiratory Arrest
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Electric Shock
5
5
Swelling
5
5
Overdose
4
4
Myocardial Infarction
4
4
Embolism/Embolus
4
4
Nausea
3
3
Bone Fracture(s)
3
3
Non specific EKG/ECG Changes
3
3
Edema
3
3
Angina
3
3
Hypersensitivity/Allergic reaction
3
3
Respiratory Distress
3
3
Complaint, Ill-Defined
3
3
Injury
3
3
Reaction
3
3
Loss of consciousness
2
2
Diaphoresis
2
2
Malaise
2
2
Brain Injury
2
2
Arrhythmia
2
2
Aneurysm
2
2
Pulmonary Embolism
2
2
Abdominal Pain
2
2
Dyspnea
2
2
Cardiopulmonary Arrest
2
2
Stroke/CVA
2
2
Unspecified Tissue Injury
2
2
Loss Of Pulse
2
2
Dizziness
2
2
Missing Value Reason
2
2
Ischemia Stroke
2
2
Thromboembolism
1
1
Foreign Body In Patient
1
1
Blood Loss
1
1
Diminished Pulse Pressure
1
1
Aortic Dissection
1
1
Ischemic Heart Disease
1
1
Suture Abrasion
1
1
Underdose
1
1
Swelling/ Edema
1
1
Renal Impairment
1
1
Abrasion
1
1
Atherosclerosis
1
1
Atrial Fibrillation
1
1
Apnea
1
1
Gangrene
1
1
Head Injury
1
1
Headache
1
1
Hepatitis
1
1
Eye Injury
1
1
Fall
1
1
Foreign Body Reaction
1
1
Inflammation
1
1
Ischemia
1
1
Embolus
1
1
Unspecified Infection
1
1
Cardiac Tamponade
1
1
Discomfort
1
1
Rupture
1
1
Ventilator Dependent
1
1
Chest Tightness/Pressure
1
1
Pallor
1
1
Low Oxygen Saturation
1
1
Obstruction/Occlusion
1
1
Numbness
1
1
ST Segment Elevation
1
1
Seizures, Focal Motor
1
1
Shock
1
1
Perforation
1
1
Pneumonia
1
1
Loss of Range of Motion
1
1
Transient Ischemic Attack
1
1
Vasoconstriction
1
1
Visual Impairment
1
1
Vomiting
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Acist Medical Systems
II
Feb-02-2016
2
B. Braun Medical, Inc.
II
Nov-03-2023
3
Bayer Healthcare
II
Sep-08-2016
4
Bayer Healthcare
II
Jul-19-2016
5
Bayer Medical Care, Inc.
II
Nov-03-2021
6
Bayer Medical Care, Inc.
II
Nov-23-2020
7
Bayer Medical Care, Inc.
II
Jan-15-2019
8
Bracco Injeneering S.A.
II
Dec-21-2018
9
LeMaitre Vascular, Inc.
II
May-04-2021
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