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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device marker, radiographic, implantable
Regulation Description Implantable clip.
Product CodeNEU
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
C4 IMAGING LLC
  SUBSTANTIALLY EQUIVALENT 1
DEVICOR MEDICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
DEVICOR MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
ELUCENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOMAGNETICS LTD
  SUBSTANTIALLY EQUIVALENT 2
HEALTH BEACONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INRAD INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MOLLI SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
MOLLI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
SOMATEX MEDICAL TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
SURGMARK GMBH
  SUBSTANTIALLY EQUIVALENT 1
VIEW POINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 45 45
2021 82 82
2022 100 100
2023 142 142
2024 247 247
2025 303 303

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 488 488
Migration 50 50
Use of Device Problem 34 34
Fracture 25 25
Migration or Expulsion of Device 23 23
Break 22 22
Patient-Device Incompatibility 22 22
Detachment of Device or Device Component 19 19
Positioning Failure 15 15
Difficult to Remove 13 13
Appropriate Term/Code Not Available 11 11
Device Markings/Labelling Problem 11 11
Insufficient Information 11 11
Patient Device Interaction Problem 11 11
Device Contamination with Chemical or Other Material 10 10
Activation, Positioning or Separation Problem 8 8
Separation Failure 8 8
Material Fragmentation 7 7
Therapeutic or Diagnostic Output Failure 7 7
Incorrect Measurement 6 6
Entrapment of Device 6 6
Mechanical Problem 6 6
Poor Quality Image 6 6
Material Split, Cut or Torn 5 5
Component Misassembled 5 5
Difficult to Insert 5 5
No Apparent Adverse Event 5 5
Material Twisted/Bent 4 4
Device-Device Incompatibility 4 4
Output Problem 4 4
Activation Problem 4 4
Defective Device 4 4
Retraction Problem 3 3
Component Missing 3 3
Unable to Obtain Readings 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Expiration Date Error 3 3
Unintended Movement 3 3
Malposition of Device 3 3
Improper or Incorrect Procedure or Method 3 3
Component or Accessory Incompatibility 3 3
Device Slipped 3 3
Device Sensing Problem 2 2
Failure to Advance 2 2
Device Appears to Trigger Rejection 2 2
Unexpected Therapeutic Results 2 2
Failure to Fire 2 2
Tear, Rip or Hole in Device Packaging 2 2
Premature Activation 2 2
Biocompatibility 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Breast Discomfort/Pain 321 321
No Clinical Signs, Symptoms or Conditions 200 200
Bacterial Infection 124 124
Swelling/ Edema 115 115
Erythema 108 108
Seroma 90 90
Foreign Body In Patient 59 59
Sleep Dysfunction 58 58
Hypersensitivity/Allergic reaction 56 56
Hematoma 50 50
Pain 46 46
Itching Sensation 42 42
Deformity/ Disfigurement 41 41
Rash 29 29
Scar Tissue 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Breast Mass 25 25
Post Operative Wound Infection 24 24
Insufficient Information 24 24
Inflammation 24 24
Necrosis 24 24
Abscess 22 22
Impaired Healing 21 21
Unspecified Infection 21 21
Erosion 18 18
Failure of Implant 17 17
Wound Dehiscence 16 16
Hemorrhage/Bleeding 15 15
Bruise/Contusion 14 14
Implant Pain 13 13
Burning Sensation 13 13
Fluid Discharge 12 12
Skin Inflammation/ Irritation 12 12
Post Traumatic Wound Infection 11 11
Foreign Body Reaction 10 10
Anxiety 8 8
Discomfort 8 8
Fistula 8 8
Device Embedded In Tissue or Plaque 8 8
Purulent Discharge 7 7
Localized Skin Lesion 7 7
Nodule 6 6
Local Reaction 6 6
Skin Discoloration 6 6
Hair Loss 5 5
Swollen Lymph Nodes/Glands 5 5
No Known Impact Or Consequence To Patient 5 5
Cellulitis 5 5
Abdominal Pain 5 5
Pancreatitis 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Carbon Medical Technologies, Inc. II Jan-30-2023
2 Devicor Medical Products Inc II May-23-2022
3 Elucent Medical Inc II Jan-06-2025
4 Hologic, Inc I Nov-26-2024
5 Hologic, Inc I May-03-2024
6 Hologic, Inc II Sep-30-2022
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