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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
  1.  K210006  MI DeTACH
CAREFUSION 2200, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPRESSION WORKS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENSITE VACULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENSITE VASCULAR
  SUBSTANTIALLY EQUIVALENT 1
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 1

MDR Year MDR Reports MDR Events
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 718 719
Gas/Air Leak 360 360
Activation Problem 349 349
Deflation Problem 252 252
Failure to Unfold or Unwrap 146 146
Adverse Event Without Identified Device or Use Problem 104 104
Difficult to Open or Close 94 94
Break 88 88
Insufficient Information 72 72
Detachment of Device or Device Component 51 51
Unintended Deflation 47 47
Crack 46 46
Leak/Splash 45 45
No Apparent Adverse Event 32 32
Inflation Problem 31 31
Failure to Seal 26 26
Mechanical Problem 25 25
Unraveled Material 25 25
Premature Activation 21 21
Material Puncture/Hole 19 19
Material Twisted/Bent 17 17
Activation, Positioning or Separation Problem 16 16
Use of Device Problem 14 14
Device Slipped 13 13
Material Separation 13 13
Material Rupture 10 10
Fluid/Blood Leak 10 10
Failure to Cut 9 9
Unintended Movement 8 8
Filling Problem 8 8
Patient Device Interaction Problem 7 7
Migration 7 7
Defective Device 6 8
Burst Container or Vessel 6 6
Delivered as Unsterile Product 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Device Contaminated During Manufacture or Shipping 5 5
Appropriate Term/Code Not Available 5 5
Device Dislodged or Dislocated 5 5
Device Contamination with Chemical or Other Material 5 5
Improper or Incorrect Procedure or Method 4 4
Therapeutic or Diagnostic Output Failure 4 4
Failure to Deflate 4 4
Misfire 4 4
Material Split, Cut or Torn 4 4
Failure to Align 4 4
Material Deformation 3 3
Infusion or Flow Problem 3 3
Decrease in Pressure 3 3
Failure to Fire 3 3

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 334 334
Hematoma 186 186
Hemorrhage/Bleeding 180 180
Insufficient Information 134 136
No Patient Involvement 33 33
Blood Loss 29 29
Pain 20 20
Bruise/Contusion 14 14
Swelling/ Edema 13 13
Injury 12 12
Pseudoaneurysm 11 11
Numbness 9 9
Death 7 7
Foreign Body In Patient 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Laceration(s) 5 5
Necrosis 5 5
Vascular Dissection 5 5
No Known Impact Or Consequence To Patient 5 5
Nerve Damage 4 4
Perforation of Vessels 3 3
Cyanosis 3 3
Unspecified Infection 3 3
Neuropathy 3 3
Diminished Pulse Pressure 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Great Vessel Perforation 3 3
Thrombosis/Thrombus 3 3
Cardiovascular Insufficiency 2 2
Ventricular Fibrillation 2 2
Unspecified Heart Problem 2 2
Cardiac Arrest 2 2
Nervous System Injury 2 2
No Code Available 2 2
Air Embolism 2 2
Skin Tears 1 1
Loss of consciousness 1 1
Ascites 1 1
Tissue Breakdown 1 1
Unspecified Tissue Injury 1 1
Intimal Dissection 1 1
Device Embedded In Tissue or Plaque 1 1
Muscle/Tendon Damage 1 1
Heart Failure/Congestive Heart Failure 1 1
Fluid Discharge 1 1
Discomfort 1 1
Erythema 1 1
Pallor 1 1
Needle Stick/Puncture 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 Maquet Cardiovascular, LLC II Sep-18-2025
5 Merit Medical Systems, Inc. II Apr-24-2020
6 North American Rescue LLC. II Sep-26-2025
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