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 ear, nose, and throat surgical tray
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. 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 CodeOGR
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2020 4 4
2021 3 3
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3
Break 2 2
Contamination /Decontamination Problem 2 2
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Contamination of Device Ingredient or Reagent 1 1
Entrapment of Device 1 1
Fire 1 1
Material Fragmentation 1 1
Component Missing 1 1
Incomplete or Missing Packaging 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Foreign Body In Patient 3 3
Insufficient Information 3 3
Superficial (First Degree) Burn 2 2
No Known Impact Or Consequence To Patient 2 2
Burn(s) 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Sep-08-2022
3 Centurion Medical Products Corporation II Feb-05-2020
4 Centurion Medical Products Corporation II Nov-15-2019
5 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
7 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
8 Medline Industries Inc II Jan-07-2021
9 ROi CPS LLC II Nov-23-2022
10 ROi CPS LLC II Jan-10-2022
11 ROi CPS LLC II Nov-18-2021
12 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
-
-