Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device stimulator, low electric field, tumor treatment
Definition Intended to treat tumors by application of low electic fields and indicated for treatment of recurrent glioblastoma multiforme (gbm) in patients who have received maximum standard therapy with continued disease progress, as defined by tumor growth or decline in neurological status.
Product CodeNZK
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 1 2 4 4 3 3 1 3 2 1 4 1 1 2

MDR Year MDR Reports MDR Events
2014 11 11
2015 23 23
2016 9 9
2017 12 12
2018 23 23
2019 21 21
2020 30 30
2021 32 32
2022 26 26
2023 29 29
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 230 230
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Wound Dehiscence 89 89
Post Operative Wound Infection 72 72
Ulcer 20 20
Fall 18 18
Laceration(s) 13 13
Seizures 12 12
Convulsion/Seizure 10 10
Death 9 9
Headache 8 8
Abscess 7 7
Cerebrospinal Fluid Leakage 6 6
Convulsion, Tonic 4 4
Post Traumatic Wound Infection 4 4
Cognitive Changes 3 3
Electric Shock 3 3
Speech Disorder 3 3
Limb Fracture 3 3
Seizures, Focal 3 3
Skin Erosion 3 3
Intracranial Hemorrhage 2 2
Infarction, Cerebral 2 2
Convulsion, Clonic 2 2
Pulmonary Embolism 2 2
Fatigue 2 2
Bone Fracture(s) 2 2
Skin Infection 2 2
Skin Inflammation/ Irritation 2 2
Hip Fracture 2 2
Vertebral Fracture 2 2
Respiratory Failure 2 2
Shaking/Tremors 1 1
Ambulation Difficulties 1 1
No Code Available 1 1
Hydrocephalus 1 1
Balance Problems 1 1
Osteomyelitis 1 1
Sensitivity of Teeth 1 1
Multiple Fractures 1 1
Solid Tumour 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematoma 1 1
Memory Loss/Impairment 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Paresis 1 1
Abrasion 1 1
Erosion 1 1
Cellulitis 1 1
Contusion 1 1
Dysphagia/ Odynophagia 1 1
Myalgia 1 1
Radiodermatitis 1 1
Anxiety 1 1
Distress 1 1
Toxicity 1 1
High Blood Pressure/ Hypertension 1 1
Seizures, Focal Motor 1 1
Skull Fracture 1 1
Strangulation 1 1
Thrombosis 1 1
Tinnitus 1 1
Seizures, Grand-Mal 1 1
Twitching 1 1

-
-