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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device marker, radiographic, implantable
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
CIANNA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEVICOR MEDICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 1
DEVICOR MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ELUCENT MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ELUCENT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDOMAGNETICS LTD
  SUBSTANTIALLY EQUIVALENT 1
ENDOMAGNETICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOCAL THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
HEALTH BEACONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 2
SOMATEX MEDICAL TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 3
SONAVEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGMARK GMBH
  SUBSTANTIALLY EQUIVALENT 1
VIEW POINT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 66 66
2019 58 58
2020 45 45
2021 82 82
2022 100 100
2023 142 142
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 176 176
Use of Device Problem 25 25
Migration 25 25
Detachment of Device or Device Component 24 24
Patient-Device Incompatibility 21 21
Positioning Failure 21 21
Difficult to Remove 16 16
Material Fragmentation 13 13
Activation, Positioning or Separation Problem 13 13
Device Markings/Labelling Problem 12 12
Device Contamination with Chemical or Other Material 12 12
Break 12 12
Device Damaged by Another Device 10 10
Component Missing 9 9
Patient Device Interaction Problem 9 9
Separation Failure 8 8
Bent 7 7
Activation Problem 7 7
Entrapment of Device 6 6
Mechanical Problem 6 6
Material Twisted/Bent 6 6
Therapeutic or Diagnostic Output Failure 6 6
Retraction Problem 5 5
Poor Quality Image 5 5
Component Misassembled 5 5
Material Split, Cut or Torn 5 5
Difficult to Insert 4 4
Migration or Expulsion of Device 4 4
Appropriate Term/Code Not Available 4 4
Output Problem 4 4
Failure to Advance 4 4
Expiration Date Error 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device Operates Differently Than Expected 3 3
Fracture 3 3
Device Slipped 3 3
Premature Activation 3 3
Unable to Obtain Readings 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Failure to Eject 3 3
Insufficient Information 3 3
Audible Prompt/Feedback Problem 2 2
Device Appears to Trigger Rejection 2 2
Unexpected Therapeutic Results 2 2
Improper or Incorrect Procedure or Method 2 2
No Audible Prompt/Feedback 2 2
Signal Artifact/Noise 2 2
Thermal Decomposition of Device 2 2
Material Discolored 2 2
Expulsion 2 2
Material Deformation 2 2
Positioning Problem 2 2
Activation Failure 2 2
Failure to Deliver 2 2
Difficult or Delayed Activation 2 2
Defective Device 2 2
Failure to Fire 2 2
Malposition of Device 2 2
Failure to Form Staple 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Chemical Problem 1 1
Communication or Transmission Problem 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
No Apparent Adverse Event 1 1
Packaging Problem 1 1
Material Protrusion/Extrusion 1 1
Device Sensing Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Device Dislodged or Dislocated 1 1
Erratic or Intermittent Display 1 1
Electromagnetic Interference 1 1
Electrical /Electronic Property Problem 1 1
Crack 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Image Display Error/Artifact 1 1
Inaudible or Unclear Audible Prompt/Feedback 1 1
Defective Component 1 1
Material Perforation 1 1
Sticking 1 1
Nonstandard Device 1 1
Failure to Power Up 1 1
Self-Activation or Keying 1 1
Material Separation 1 1
Poor Visibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 127 127
Breast Discomfort/Pain 83 83
Foreign Body In Patient 52 52
No Consequences Or Impact To Patient 51 51
Hypersensitivity/Allergic reaction 35 35
Sleep Dysfunction 31 31
No Known Impact Or Consequence To Patient 25 25
Pain 20 20
Erythema 19 19
Patient Problem/Medical Problem 17 17
Reaction 16 16
Itching Sensation 13 13
Insufficient Information 13 13
Bacterial Infection 12 12
Device Embedded In Tissue or Plaque 12 12
Burning Sensation 8 8
Hemorrhage/Bleeding 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Inflammation 7 7
Hematoma 7 7
Foreign Body Reaction 7 7
Unspecified Infection 6 6
No Patient Involvement 6 6
No Code Available 5 5
Necrosis 5 5
Seroma 4 4
Failure of Implant 4 4
Swelling 4 4
No Information 4 4
Swelling/ Edema 3 3
Deformity/ Disfigurement 3 3
Abdominal Pain 3 3
Scar Tissue 2 2
Rash 2 2
Inadequate Pain Relief 2 2
Skin Irritation 2 2
Discomfort 2 2
Injury 2 2
Burn, Thermal 2 2
Blood Loss 2 2
Bronchospasm 2 2
Weight Changes 2 2
Skin Infection 2 2
Unspecified Tissue Injury 2 2
Implant Pain 2 2
Unintended Radiation Exposure 2 2
Increased Sensitivity 1 1
Localized Skin Lesion 1 1
Numbness 1 1
Breast Mass 1 1
Sweating 1 1
Post Operative Wound Infection 1 1
Palpitations 1 1
Shaking/Tremors 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Pancreatitis 1 1
Fibrosis 1 1
Tissue Breakdown 1 1
Arthralgia 1 1
Laceration(s) of Esophagus 1 1
Impaired Healing 1 1
Tinnitus 1 1
Tissue Damage 1 1
Visual Impairment 1 1
Discharge 1 1
Urticaria 1 1
Anxiety 1 1
Local Reaction 1 1
Loss of Range of Motion 1 1
Septic Shock 1 1
Skin Erosion 1 1
Neurological Deficit/Dysfunction 1 1
Muscular Rigidity 1 1
Irritation 1 1
Abrasion 1 1
Abscess 1 1
Anemia 1 1
Arthritis 1 1
Asthma 1 1
Calcium Deposits/Calcification 1 1
Emotional Changes 1 1
Fatigue 1 1
Fistula 1 1
Wound Dehiscence 1 1
Glaucoma 1 1
Granuloma 1 1
Hair Loss 1 1

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 Hologic, Inc II Sep-30-2022
4 Somatex Medical Technologies GmbH II Jan-24-2018
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