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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ventilator, continuous, facility use
Product CodeCBK
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIMAR S.P.A
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAEGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
DRAGERWERK AG & CO. KGAA
  SUBSTANTIALLY EQUIVALENT 1
FISHER & PAYKEL HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
HAMILTON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 4
HAMITON MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
IMTMEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
INOVYTECH MEDICAL SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICA CARE AB
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CRITICAL CARE AB
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
NIHON KOHDEN ORANGEMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORIGIN MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
  1.  K213098  Panther 5
RESPIRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SLEEPNET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
VENTIS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYAIRE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 8738 9140

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation I Jun-26-2024
2 Baxter Healthcare Corporation I Feb-24-2023
3 Breas Medical, Inc. II Apr-15-2022
4 Covidien I Aug-02-2024
5 Covidien Llc I Dec-09-2021
6 Covidien Llc II Nov-06-2020
7 Draeger Medical, Inc. I Aug-18-2023
8 Draeger Medical, Inc. I Jul-08-2023
9 Draeger Medical, Inc. I Feb-24-2023
10 Draeger Medical, Inc. II Apr-04-2022
11 Draeger Medical, Inc. II Oct-14-2021
12 Draeger Medical, Inc. II May-28-2021
13 GE Healthcare, LLC I Jun-06-2022
14 GE Healthcare, LLC II Aug-24-2020
15 GE Healthcare, LLC II Dec-17-2019
16 Getinge Group Logistics America, LLC II Oct-09-2020
17 Getinge Usa Sales Inc II Aug-24-2022
18 Getinge Usa Sales Inc I Aug-22-2022
19 Hamilton Medical AG I Jun-18-2024
20 Hamilton Medical AG II Apr-25-2023
21 Hamilton Medical AG II Nov-18-2022
22 Hamilton Medical AG I Aug-19-2022
23 Hamilton Medical AG I Jul-11-2019
24 Hamilton Medical, Inc. I Sep-20-2023
25 Hamilton Medical, Inc. I Jul-21-2023
26 Hill-Rom Manufacturing, Inc. II Nov-24-2020
27 Medtronic formerly Covidien I Apr-25-2022
28 NIHON KOHDEN ORANGEMED, INC II Sep-08-2021
29 Percussionaire Corporation I Jan-17-2024
30 Percussionaire Corporation I Jan-17-2024
31 Percussionaire Corporation II Nov-07-2023
32 Philips Respironics, Inc. I Sep-05-2024
33 Philips Respironics, Inc. I Apr-17-2024
34 Philips Respironics, Inc. II Jan-04-2024
35 Philips Respironics, Inc. II Jul-07-2023
36 Philips Respironics, Inc. I Jun-02-2023
37 Philips Respironics, Inc. I Apr-03-2023
38 Philips Respironics, Inc. I Jan-06-2023
39 Philips Respironics, Inc. I Mar-18-2022
40 Philips Respironics, Inc. I Jan-22-2022
41 Philips Respironics, Inc. II Aug-13-2021
42 Philips Respironics, Inc. I Jul-15-2021
43 Philips Respironics, Inc. I Feb-15-2020
44 ResMed Ltd. I Oct-23-2023
45 Ventec Life Systems, Inc. I Feb-23-2024
46 Ventec Life Systems, Inc. II Jun-21-2021
47 Vyaire Medical II Jun-15-2023
48 Vyaire Medical I Feb-16-2022
49 Vyaire Medical II Mar-04-2020
50 ZOLL Medical Corporation I Jun-20-2024
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