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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clamp, vascular
Regulation Description Vascular clamp.
Product CodeDXC
Regulation Number 870.4450
Device Class 2


Premarket Reviews
ManufacturerDecision
ARC TRAUMA, LLC
  SUBSTANTIALLY EQUIVALENT 1
BEIJING DEMAX MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BIOREP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPRESSION WORKS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENSITE VACULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENSITE VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
KONO SEISAKUSHO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL INGENUITIES
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
NINGBO DIZEGENS MEDICAL SCIENCE CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR GRAFT SOLUTIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
VASOINNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 393 394
2020 404 404
2021 371 371
2022 273 275
2023 674 674
2024 375 375
2025 448 449

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 804 805
Activation Problem 409 409
Gas/Air Leak 390 390
Deflation Problem 254 254
Failure to Unfold or Unwrap 168 168
Adverse Event Without Identified Device or Use Problem 119 119
Break 105 105
Difficult to Open or Close 97 97
Insufficient Information 75 75
Leak/Splash 71 71
Crack 61 61
Detachment of Device or Device Component 57 57
Inflation Problem 47 48
Unintended Deflation 47 47
Activation, Positioning or Separation Problem 37 37
Mechanical Problem 37 37
Unraveled Material 36 36
Material Rupture 34 34
No Apparent Adverse Event 32 32
Failure to Seal 26 26
Premature Activation 26 26
Appropriate Term/Code Not Available 24 24
Material Puncture/Hole 23 23
Material Twisted/Bent 20 20
Material Separation 16 16
Burst Container or Vessel 16 16
Use of Device Problem 15 15
Fluid/Blood Leak 14 14
Filling Problem 14 14
Device Slipped 13 13
Defective Device 11 13
Migration 10 10
Failure to Cut 9 9
Unintended Movement 9 9
Patient Device Interaction Problem 9 9
Decrease in Pressure 8 8
Therapeutic or Diagnostic Output Failure 8 8
Difficult to Insert 7 7
Delivered as Unsterile Product 6 6
Component Missing 6 6
Device Contamination with Chemical or Other Material 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Material Deformation 5 5
Failure to Fire 5 5
Device Contaminated During Manufacture or Shipping 5 5
Misfire 5 5
Device Dislodged or Dislocated 5 5
Positioning Problem 5 5
Peeled/Delaminated 5 5
Physical Resistance/Sticking 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1670 1671
No Consequences Or Impact To Patient 553 553
Hematoma 208 208
Hemorrhage/Bleeding 185 185
Insufficient Information 134 136
No Known Impact Or Consequence To Patient 103 103
Blood Loss 69 69
No Patient Involvement 59 59
Pain 20 20
Bruise/Contusion 14 14
Pseudoaneurysm 13 13
Swelling/ Edema 13 13
Injury 12 12
No Information 10 11
Numbness 9 9
Death 9 9
Foreign Body In Patient 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Vascular Dissection 5 5
Necrosis 5 5
Laceration(s) 5 5
Unspecified Infection 4 4
Nerve Damage 4 4
No Code Available 3 3
Diminished Pulse Pressure 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Perforation of Vessels 3 3
Cardiac Arrest 3 3
Neuropathy 3 3
Ventricular Fibrillation 3 3
Thrombosis/Thrombus 3 3
Cyanosis 3 3
Great Vessel Perforation 3 3
Air Embolism 3 3
Nervous System Injury 2 2
Rupture 2 2
Failure of Implant 2 2
Unspecified Heart Problem 2 2
Cardiovascular Insufficiency 2 2
Renal Failure 1 1
Unspecified Tissue Injury 1 1
Muscle/Tendon Damage 1 1
Hypoxia 1 1
Tissue Damage 1 1
Skin Tears 1 1
Loss of consciousness 1 1
Ascites 1 1
Low Blood Pressure/ Hypotension 1 1
Tissue Breakdown 1 1
Intimal Dissection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-12-2024
2 Baxter Healthcare Corporation II Jan-05-2024
3 Baxter Healthcare Corporation II Apr-29-2022
4 Edwards Lifesciences, LLC I Jun-11-2019
5 Edwards Lifesciences, LLC II Apr-06-2019
6 Integra LifeSciences Corp. II Aug-30-2019
7 Maquet Cardiovascular, LLC II Sep-18-2025
8 Merit Medical Systems, Inc. II Apr-24-2020
9 North American Rescue LLC. II Sep-26-2025
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