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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cuff, nerve
Product CodeJXI
Regulation Number 882.5275
Device Class 2


Premarket Reviews
ManufacturerDecision
ALAFAIR BIOSCIENCES INC
  SUBSTANTIALLY EQUIVALENT 2
AXOGEN CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BIOCIRCUIT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCIRCUIT TECHNOLOGIES, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CELESTRAY BIOTECH COMPANY, LLC.,
  SUBSTANTIALLY EQUIVALENT 1
MOCHIDA PHARMACEUTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MONARCH BIOIMPLANTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
RENERVE LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 5 5
2021 3 3
2022 8 8
2023 15 15
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18 18
Migration 13 13
Appropriate Term/Code Not Available 7 7
Use of Device Problem 2 2
Device Appears to Trigger Rejection 2 2
Peeled/Delaminated 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Contamination 1 1
Failure to Fold 1 1
Inadequacy of Device Shape and/or Size 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Impaired Healing 14 14
No Clinical Signs, Symptoms or Conditions 6 6
Peripheral Nervous Injury 4 4
Inflammation 3 3
Pain 3 3
Skin Infection 2 2
No Code Available 2 2
Purulent Discharge 2 2
Post Operative Wound Infection 2 2
Injury 2 2
Fever 2 2
Numbness 2 2
Swelling 2 2
Swelling/ Edema 2 2
Unspecified Infection 1 1
Tingling 1 1
Hypersensitivity/Allergic reaction 1 1
Wound Dehiscence 1 1
Skin Irritation 1 1
Failure of Implant 1 1
Nausea 1 1
Skin Inflammation/ Irritation 1 1
Synovitis 1 1
Post Traumatic Wound Infection 1 1
Erythema 1 1
Abscess 1 1
Bacterial Infection 1 1
Granuloma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Apr-25-2023
2 Integra LifeSciences Corp. III Mar-11-2020
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