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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device platelet and plasma separator for bone graft handling
Definition Preparation of autologous platelet rich plasma from a small sample of peripheral blood for mixing with bone graft to improve handling characteristics.
Product CodeORG
Regulation Number 864.9245
Device Class 2


Premarket Reviews
ManufacturerDecision
AEON BIOTHERAPEUTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
ALLIANCE PARTNERS LLC
  SUBSTANTIALLY EQUIVALENT 2
APEX BIOLOGIX
  SUBSTANTIALLY EQUIVALENT 1
ARTERIOCYTE MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 8
B.T.I BIOTECHNOLOGY INSTITUTE, S.L.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CASCADE MEDICAL ENTERPRISES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CELLING BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DSM BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
EMCYTE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FIDIA FARMACEUTICI S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
GENESIS BIOLOGICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HAELEON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALEON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLDING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
LUVO MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RANFAC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
REAPPLIX APS
  SUBSTANTIALLY EQUIVALENT 1
ROYAL BIOLOGICS INC
  SUBSTANTIALLY EQUIVALENT 2
ROYAL BIOLOGICS LLC
  SUBSTANTIALLY EQUIVALENT 1
SUNEVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO BCT, INC
  SUBSTANTIALLY EQUIVALENT 1
YTS GLOBAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 6 6
2017 3 3
2018 10 10
2019 11 11
2020 20 20
2021 25 25
2022 25 25
2023 83 83
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 42 42
Defective Device 30 30
Leak/Splash 28 28
Material Puncture/Hole 16 16
Break 15 15
Output Problem 11 11
Use of Device Problem 9 9
Device Expiration Issue 6 6
Improper or Incorrect Procedure or Method 6 6
Device Emits Odor 6 6
Off-Label Use 6 6
Insufficient Flow or Under Infusion 5 5
Smoking 5 5
Display or Visual Feedback Problem 5 5
Inadequate User Interface 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Device Handling Problem 4 4
Volume Accuracy Problem 4 4
Obstruction of Flow 4 4
Mechanical Problem 4 4
Fitting Problem 4 4
Overheating of Device 3 3
Coagulation in Device or Device Ingredient 3 3
Expiration Date Error 3 3
Device Markings/Labelling Problem 3 3
Noise, Audible 3 3
Unexpected Shutdown 3 3
Difficult or Delayed Separation 2 2
No Flow 2 2
Explosion 2 2
Insufficient Information 2 2
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Detachment of Device or Device Component 2 2
Patient-Device Incompatibility 2 2
Calibration Problem 2 2
Component Missing 2 2
Crack 2 2
Disconnection 2 2
Burst Container or Vessel 2 2
Difficult to Insert 2 2
Defective Component 2 2
Difficult to Remove 2 2
Failure to Sense 1 1
Problem with Sterilization 1 1
Microbial Contamination of Device 1 1
No Device Output 1 1
Peeled/Delaminated 1 1
Device Difficult to Setup or Prepare 1 1
Increase in Pressure 1 1
Defective Alarm 1 1
Backflow 1 1
Component Falling 1 1
Contamination 1 1
Misconnection 1 1
Nonstandard Device 1 1
Loose or Intermittent Connection 1 1
Excess Flow or Over-Infusion 1 1
Device Contamination with Body Fluid 1 1
Structural Problem 1 1
Failure to Advance 1 1
Device Displays Incorrect Message 1 1
Connection Problem 1 1
Difficult to Advance 1 1
Difficult to Open or Close 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Gas/Air Leak 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
No Fail-Safe Mechanism 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Output below Specifications 1 1
Appropriate Term/Code Not Available 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Failure to Eject 1 1
Patient Device Interaction Problem 1 1
Air/Gas in Device 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 99 99
Insufficient Information 64 64
No Known Impact Or Consequence To Patient 28 28
Exposure to Body Fluids 10 10
Swelling/ Edema 7 7
No Code Available 3 3
Unspecified Infection 3 3
Inflammation 2 2
Pain 2 2
Swelling 2 2
Autoimmune Reaction 2 2
Needle Stick/Puncture 2 2
No Patient Involvement 2 2
Device Embedded In Tissue or Plaque 2 2
No Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Syncope/Fainting 1 1
Osteomyelitis 1 1
Subcutaneous Nodule 1 1
Nodule 1 1
Reaction to Medicinal Component of Device 1 1
Blood Loss 1 1
Bacterial Infection 1 1
Swollen Lymph Nodes 1 1
No Consequences Or Impact To Patient 1 1
Irritation 1 1
Laceration(s) 1 1
Erythema 1 1
Fever 1 1
Hair Loss 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1

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