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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurological tray
Definition This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOJG
Regulation Number 882.4525
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2017 1 1
2018 7 7
2019 3 3
2020 8 8
2021 9 9
2022 11 11
2023 9 9
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 11 11
Contamination 9 9
Break 8 8
Material Separation 6 6
Material Fragmentation 5 5
Device Contamination with Chemical or Other Material 5 5
Material Frayed 3 3
Contamination /Decontamination Problem 3 3
Detachment of Device or Device Component 3 3
Component Incompatible 3 3
Loose or Intermittent Connection 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Integrity Problem 3 3
Incomplete or Missing Packaging 2 2
Crack 2 2
Delivered as Unsterile Product 2 2
Fire 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Damaged by Another Device 1 1
Inaccurate Flow Rate 1 1
Product Quality Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Nonstandard Device 1 1
Connection Problem 1 1
Flaked 1 1
Filling Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1
Unexpected Color 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
Insufficient Information 9 9
No Known Impact Or Consequence To Patient 8 8
Foreign Body In Patient 7 7
No Consequences Or Impact To Patient 5 5
Local Reaction 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Sleep Dysfunction 1 1
No Information 1 1
Burn(s) 1 1
No Patient Involvement 1 1
Dyspnea 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Aug-07-2024
3 American Contract Systems, Inc. II Jan-26-2024
4 American Contract Systems, Inc. II Sep-08-2022
5 American Contract Systems, Inc. II May-06-2022
6 Avid Medical, Inc. II Mar-19-2020
7 Cardinal Health 200, LLC II Jul-10-2024
8 Cardinal Health 200, LLC II Oct-10-2023
9 Customed, Inc II Apr-14-2016
10 Customed, Inc II Sep-03-2015
11 Customed, Inc I Dec-16-2014
12 Customed, Inc I Aug-29-2014
13 Integra LifeSciences Corp. II Mar-22-2022
14 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
20 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
21 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
22 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
23 Medline Industries Inc II Dec-10-2021
24 ROi CPS LLC II Apr-25-2023
25 ROi CPS LLC II Nov-23-2022
26 Stradis Medical, LLC dba Stradis Healthcare II Apr-04-2022
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