|
Device |
ventilator, continuous, facility use |
Product Code | CBK |
Regulation Number |
868.5895
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AIRON CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO-MED DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BREATHE TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARDINAL HEALTH 207, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COSMED S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COVIDIEN LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DATEX-OHMEDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DATEX-OHMEDA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DIMAR S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAEGER MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAEGER MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAEGERWERK AG & CO KGAA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAEGERWERK AG & CO. KGAA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DRAGER MEDICAL AG & CO. KGAA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAGERWERK AG & CO. KGAA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVENT MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EVENT MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FISHER & PAYKEL HEALTHCARE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FISHER & PAYKEL HEALTHCARE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FISHER AND PAYKEL HEALTHCARE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLIGHT MEDICAL INNOVATIONS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
FLIGHT MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HAMILTON MEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
18
|
HAMITON MEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HSINER CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPACT INSTRUMENTATION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IMTMEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INOVYTECH MEDICAL SOLUTIONS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LEVEL-5, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAQUET CRITICA CARE AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAQUET CRITICAL CARE AB |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NEWPORT MEDICAL INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NIHON KOHDEN ORANGEMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NIHON KOHDEN ORANGEMED, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORICARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORIGIN MEDICAL DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PAN-AMERICA HYPERBARICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROVIDENCE GLOBAL MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PULMONETIC SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESMED LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESMED LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
RESPIRONICS CALIFORNIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
RESPIRONICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RESPIRONICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SLEEPNET CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SPACELABS HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPACELABS HEALTHCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECME S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VENTEC LIFE SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VENTIS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VERSAMED MEDICAL SYSTEMS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VERSAMED MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VYAIRE MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZOLL MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Baxter Healthcare Corporation |
I |
Jun-26-2024 |
2 |
Baxter Healthcare Corporation |
I |
Feb-24-2023 |
3 |
Biomed Devices |
II |
Jan-27-2011 |
4 |
Breas Medical, Inc. |
II |
Apr-15-2022 |
5 |
COVIDIEN LLC |
I |
Dec-18-2018 |
6 |
CareFusion 203, Inc. |
I |
Sep-19-2014 |
7 |
CareFusion 203, Inc. |
I |
Jul-16-2012 |
8 |
CareFusion 203, Inc. |
I |
Oct-26-2011 |
9 |
CareFusion 203, Inc. |
II |
Aug-10-2010 |
10 |
CareFusion 203, Inc. |
II |
Feb-25-2010 |
11 |
Carefusion 211 Inc |
I |
Jan-11-2012 |
12 |
Carefusion 211 Inc dba Carefusion |
I |
Jun-13-2016 |
13 |
Carefusion 211 Inc dba Carefusion |
I |
May-26-2015 |
14 |
Carefusion 211 Inc dba Carefusion |
I |
Sep-27-2013 |
15 |
Covidien |
I |
Aug-02-2024 |
16 |
Covidien |
I |
Jan-03-2014 |
17 |
Covidien LLC |
II |
Mar-27-2018 |
18 |
Covidien LP (formerly Nellcor Puritan Bennett Inc.) |
II |
Mar-17-2016 |
19 |
Covidien LP (formerly Nellcor Puritan Bennett Inc.) |
I |
Aug-14-2015 |
20 |
Covidien LP (formerly Nellcor Puritan Bennett Inc.) |
II |
Feb-05-2015 |
21 |
Covidien Llc |
I |
Dec-09-2021 |
22 |
Covidien Llc |
II |
Nov-06-2020 |
23 |
Datex-Ohmeda, Inc. |
II |
Aug-08-2018 |
24 |
Datex-Ohmeda, Inc. |
II |
Jun-01-2018 |
25 |
Del Mar Reynolds Medical, Ltd. |
II |
Mar-14-2017 |
26 |
Del Mar Reynolds Medical, Ltd. |
II |
Apr-20-2015 |
27 |
Del Mar Reynolds Medical, Ltd. |
I |
Apr-12-2014 |
28 |
Del Mar Reynolds Medical, Ltd. |
II |
Jul-19-2013 |
29 |
Del Mar Reynolds Medical, Ltd. |
I |
Mar-20-2013 |
30 |
Draeger Medical Systems, Inc. |
I |
Mar-28-2014 |
31 |
Draeger Medical Systems, Inc. |
II |
Oct-07-2010 |
32 |
Draeger Medical, Inc. |
I |
Aug-18-2023 |
33 |
Draeger Medical, Inc. |
I |
Jul-08-2023 |
34 |
Draeger Medical, Inc. |
I |
Feb-24-2023 |
35 |
Draeger Medical, Inc. |
II |
Apr-04-2022 |
36 |
Draeger Medical, Inc. |
II |
Oct-14-2021 |
37 |
Draeger Medical, Inc. |
II |
May-28-2021 |
38 |
Draeger Medical, Inc. |
II |
May-29-2018 |
39 |
Draeger Medical, Inc. |
I |
Aug-04-2016 |
40 |
Draeger Medical, Inc. |
I |
Feb-25-2016 |
41 |
Draeger Medical, Inc. |
I |
Feb-03-2016 |
42 |
Draeger Medical, Inc. |
I |
Dec-23-2015 |
43 |
Draeger Medical, Inc. |
I |
Aug-14-2015 |
44 |
Draeger Medical, Inc. |
II |
May-14-2009 |
45 |
Event Medical LTD |
I |
Nov-19-2015 |
46 |
Flight Medical Ltd. |
I |
Feb-21-2012 |
47 |
GE Healthcare |
II |
Mar-24-2015 |
48 |
GE Healthcare, LLC |
I |
Jun-06-2022 |
49 |
GE Healthcare, LLC |
II |
Aug-24-2020 |
50 |
GE Healthcare, LLC |
II |
Dec-17-2019 |
51 |
GE Healthcare, LLC |
I |
Nov-30-2018 |
52 |
GE Healthcare, LLC |
I |
Jun-17-2012 |
53 |
GE Medical Systems, LLC |
II |
Jan-21-2016 |
54 |
Getinge Group Logistics America, LLC |
II |
Oct-09-2020 |
55 |
Getinge Usa Sales Inc |
II |
Aug-24-2022 |
56 |
Getinge Usa Sales Inc |
I |
Aug-22-2022 |
57 |
Hamilton Medical AG |
I |
Jun-18-2024 |
58 |
Hamilton Medical AG |
II |
Apr-25-2023 |
59 |
Hamilton Medical AG |
II |
Nov-18-2022 |
60 |
Hamilton Medical AG |
I |
Aug-19-2022 |
61 |
Hamilton Medical AG |
I |
Jul-11-2019 |
62 |
Hamilton Medical AG |
II |
Aug-14-2018 |
63 |
Hamilton Medical AG |
II |
Apr-12-2018 |
64 |
Hamilton Medical Inc |
I |
Jan-31-2013 |
65 |
Hamilton Medical Inc |
II |
Mar-07-2012 |
66 |
Hamilton Medical Inc |
II |
Apr-08-2011 |
67 |
Hamilton Medical, Inc. |
I |
Sep-20-2023 |
68 |
Hamilton Medical, Inc. |
I |
Jul-21-2023 |
69 |
Hamilton Medical, Inc. |
II |
Nov-28-2016 |
70 |
Hamilton Medical, Inc. |
II |
May-09-2016 |
71 |
Hamilton Medical, Inc. |
I |
Nov-04-2015 |
72 |
Hamilton Medical, Inc. |
II |
Jul-10-2015 |
73 |
Hamilton Medical, Inc. |
II |
Nov-06-2013 |
74 |
Hill-Rom Manufacturing, Inc. |
II |
Nov-24-2020 |
75 |
Impact Instrumentation, Inc. |
III |
Aug-07-2012 |
76 |
Impact Instrumentation, Inc. |
II |
Aug-29-2011 |
77 |
MAQUET Inc. |
II |
Jan-05-2010 |
78 |
MAQUET Inc. |
II |
May-12-2009 |
79 |
MAQUET Inc. |
II |
Feb-03-2009 |
80 |
Maquet Cardiovascular Us Sales, Llc |
I |
Apr-26-2013 |
81 |
Maquet Inc. |
II |
Apr-03-2012 |
82 |
Maquet Inc. |
II |
Dec-02-2011 |
83 |
Maquet Inc. |
II |
Jun-23-2011 |
84 |
Medtronic formerly Covidien |
I |
Apr-25-2022 |
85 |
NIHON KOHDEN ORANGEMED, INC |
II |
Sep-08-2021 |
86 |
Nellcor Puritan Bennett Inc. (dba Covidien LP) |
I |
Dec-09-2014 |
87 |
Nellcor Puritan Bennett Inc. (dba Covidien LP) |
I |
Oct-28-2014 |
88 |
Nellcor Puritan Bennett Inc. (dba Covidien LP) |
II |
Jun-20-2014 |
89 |
Nellcor Puritan Bennett Inc. (dba Covidien LP) |
II |
Jun-17-2014 |
90 |
Nellcor Puritan Bennett Inc. (dba Covidien LP) |
II |
May-09-2014 |
91 |
Nellcor Puritan Bennett Inc. (dba Covidien LP) |
II |
Jan-24-2014 |
92 |
Newport Medical Instruments Inc |
I |
Apr-10-2017 |
93 |
Newport Medical Instruments Inc |
I |
Apr-14-2014 |
94 |
Newport Medical Instruments Inc |
I |
Apr-26-2013 |
95 |
Newport Medical Instruments Inc |
II |
Jun-08-2011 |
96 |
Newport Medical Instruments Inc |
II |
Jun-02-2011 |
97 |
Newport Medical Instruments Inc |
II |
May-27-2011 |
98 |
Newport Medical Instruments Inc |
II |
May-26-2011 |
99 |
Newport Medical Instruments Inc |
II |
May-26-2011 |
100 |
Newport Medical Instruments Inc |
II |
May-19-2010 |
|
|
|
|