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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device injector and syringe, angiographic
Product CodeDXT
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
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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