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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
CARBON MEDICAL TECHNOLOGIES, INC.
  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 400 400

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 546 546
Migration 50 50
Use of Device Problem 40 40
Break 28 28
Fracture 26 26
Migration or Expulsion of Device 24 24
Patient-Device Incompatibility 24 24
Positioning Failure 19 19
Detachment of Device or Device Component 19 19
Difficult to Remove 17 17
Patient Device Interaction Problem 14 14
Insufficient Information 12 12
Device Markings/Labelling Problem 12 12
Appropriate Term/Code Not Available 11 11
Device Contamination with Chemical or Other Material 10 10
Separation Failure 10 10
Therapeutic or Diagnostic Output Failure 8 8
Activation, Positioning or Separation Problem 8 8
Material Fragmentation 7 7
Poor Quality Image 6 6
No Apparent Adverse Event 6 6
Mechanical Problem 6 6
Entrapment of Device 6 6
Incorrect Measurement 6 6
Difficult to Insert 6 6
Component Misassembled 5 5
Material Split, Cut or Torn 5 5
Defective Device 5 5
Material Twisted/Bent 5 5
Activation Problem 4 4
Device Dislodged or Dislocated 4 4
Output Problem 4 4
Malposition of Device 4 4
Unintended Movement 4 4
Material Deformation 4 4
Device-Device Incompatibility 4 4
Device Appears to Trigger Rejection 4 4
Tear, Rip or Hole in Device Packaging 3 3
Retraction Problem 3 3
Nonstandard Device 3 3
Component Missing 3 3
Improper or Incorrect Procedure or Method 3 3
Device Slipped 3 3
Unable to Obtain Readings 3 3
Component or Accessory Incompatibility 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Expiration Date Error 3 3
Biocompatibility 2 2
Premature Activation 2 2
Self-Activation or Keying 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Breast Discomfort/Pain 374 374
No Clinical Signs, Symptoms or Conditions 219 219
Bacterial Infection 139 139
Swelling/ Edema 132 132
Erythema 117 117
Seroma 97 97
Sleep Dysfunction 69 69
Foreign Body In Patient 65 65
Hypersensitivity/Allergic reaction 64 64
Deformity/ Disfigurement 58 58
Hematoma 53 53
Pain 51 51
Itching Sensation 49 49
Breast Mass 46 46
Scar Tissue 35 35
Rash 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Insufficient Information 27 27
Inflammation 27 27
Necrosis 27 27
Post Operative Wound Infection 25 25
Abscess 23 23
Unspecified Infection 22 22
Impaired Healing 21 21
Erosion 20 20
Failure of Implant 19 19
Wound Dehiscence 18 18
Skin Inflammation/ Irritation 16 16
Hemorrhage/Bleeding 16 16
Burning Sensation 15 15
Bruise/Contusion 15 15
Fluid Discharge 13 13
Implant Pain 13 13
Post Traumatic Wound Infection 11 11
Discomfort 10 10
Foreign Body Reaction 10 10
Anxiety 8 8
Fistula 8 8
Device Embedded In Tissue or Plaque 8 8
Unspecified Tissue Injury 7 7
Purulent Discharge 7 7
Localized Skin Lesion 7 7
Nodule 6 6
Local Reaction 6 6
Cellulitis 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
Abdominal Pain 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 ENDOMAGNETICS LTD II Oct-24-2025
4 Elucent Medical Inc II Jan-06-2025
5 Hologic, Inc I Nov-26-2024
6 Hologic, Inc I May-03-2024
7 Hologic, Inc II Sep-30-2022
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