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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, tracheal (w/wo connector)
Product CodeBTR
Regulation Number 868.5730
Device Class 2


Premarket Reviews
ManufacturerDecision
A.R GUIDE IN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRYAN MEDICAL , INC.
  SUBSTANTIALLY EQUIVALENT 1
BRYAN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
ETVIEW LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGXI YIKANG MEDICAL INSTRUMENT GROUP CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NEVAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
SALTER LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SECURISYN MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEXMEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VENNER MEDICAL (SINGAPORE) PTE LTD
  SUBSTANTIALLY EQUIVALENT 1
WELL LEAD MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZHANJIANG STAR ENTERPRISE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 975 975
2019 1379 1379
2020 1070 1070
2021 1329 1329
2022 1132 1132
2023 1134 1134

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation I Jul-30-2019
2 Covidien II Apr-01-2023
3 Flexicare Medical Ltd. I Nov-26-2020
4 Smiths Medical ASD Inc. II Oct-27-2021
5 TELEFLEX LLC I Jun-29-2023
6 TELEFLEX LLC II Jan-23-2023
7 TELEFLEX MEDICAL INC II Jul-10-2020
8 Teleflex Medical I Sep-09-2019
9 Teleflex Medical I Jun-19-2019
10 Teleflex Medical II May-29-2019
11 Teleflex Medical Europe Ltd II Aug-19-2021
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