|
Device |
gas-machine, anesthesia |
Product Code | BSZ |
Regulation Number |
868.5160
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADVANCED INSTRUMENTATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CODONICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DATASCOPE CORP., PATIENT MONITORING DIVISION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DATEX-OHMEDA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DATEX-OHMEDA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
DRAEGER MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DRÄGERWERK AG CO. KGAA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HEALTHCARE FINLAND OY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MAQUET CRITICAL CARE AB |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
MCKESSON TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MINDRAY DS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORICARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS ANESTHESIA CARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
THORNHILL RESEARCH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Accutron Inc |
I |
Oct-09-2012 |
2 |
Beckman Coulter Inc. |
II |
Aug-30-2016 |
3 |
Blease Medical Equipment, Ltd. |
II |
Apr-16-2010 |
4 |
Del Mar Reynolds Medical, Ltd. |
II |
May-16-2017 |
5 |
Del Mar Reynolds Medical, Ltd. |
I |
Nov-20-2013 |
6 |
Del Mar Reynolds Medical, Ltd. |
II |
Dec-19-2012 |
7 |
Draeger Medical Systems, Inc. |
II |
Sep-23-2010 |
8 |
Draeger Medical, Inc. |
I |
Apr-18-2024 |
9 |
Draeger Medical, Inc. |
II |
Jan-14-2022 |
10 |
Draeger Medical, Inc. |
II |
Jun-19-2018 |
11 |
Draeger Medical, Inc. |
I |
May-08-2018 |
12 |
Draeger Medical, Inc. |
I |
Dec-12-2015 |
13 |
Draeger Medical, Inc. |
II |
Jul-27-2015 |
14 |
Draeger Medical, Inc. |
I |
Oct-10-2013 |
15 |
Draegerwerk Ag & Co. Kgaa |
II |
Feb-01-2024 |
16 |
GE Healthcare |
II |
Apr-02-2015 |
17 |
GE Healthcare |
II |
Jul-30-2009 |
18 |
GE Healthcare |
II |
Jun-23-2009 |
19 |
GE Healthcare, LLC |
II |
Jul-20-2022 |
20 |
GE Healthcare, LLC |
I |
Jul-19-2022 |
21 |
GE Healthcare, LLC |
II |
Jun-24-2022 |
22 |
GE Healthcare, LLC |
II |
Sep-30-2021 |
23 |
GE Healthcare, LLC |
II |
Oct-30-2020 |
24 |
GE Healthcare, LLC |
I |
Jan-23-2020 |
25 |
GE Healthcare, LLC |
II |
Dec-17-2019 |
26 |
GE Healthcare, LLC |
II |
Nov-09-2018 |
27 |
GE Healthcare, LLC |
II |
Mar-26-2018 |
28 |
GE Healthcare, LLC |
II |
May-24-2017 |
29 |
GE Healthcare, LLC |
II |
Dec-14-2016 |
30 |
GE Healthcare, LLC |
I |
Oct-15-2013 |
31 |
GE Healthcare, LLC |
I |
Oct-15-2013 |
32 |
GE Healthcare, LLC |
II |
Sep-06-2013 |
33 |
GE Healthcare, LLC |
II |
Jun-03-2013 |
34 |
GE Healthcare, LLC |
II |
Oct-06-2010 |
35 |
GE Medical Systems China Co., Ltd. |
II |
Aug-30-2018 |
36 |
GE Medical Systems China Co., Ltd. |
II |
Feb-09-2018 |
37 |
GE Medical Systems, LLC |
II |
Apr-22-2016 |
38 |
GE Medical Systems, LLC |
II |
Apr-13-2016 |
39 |
GE Medical Systems, LLC |
II |
Jan-21-2016 |
40 |
Ge Healthcare, Llc |
I |
May-11-2010 |
41 |
Getinge Group Logistics America, LLC |
II |
Mar-05-2021 |
42 |
Getinge Usa Sales Inc |
I |
May-31-2024 |
43 |
Getinge Usa Sales Inc |
II |
Feb-06-2024 |
44 |
Getinge Usa Sales Inc |
I |
Jan-26-2023 |
45 |
Getinge Usa Sales Inc |
II |
Dec-07-2022 |
46 |
Getinge Usa Sales Inc |
I |
Jun-23-2022 |
47 |
Getinge Usa Sales Inc |
I |
Jan-10-2022 |
48 |
MCKESSON TECHNOLOGIES INC. |
I |
Mar-05-2014 |
49 |
Maquet Cardiovascular Us Sales, Llc |
I |
Feb-22-2016 |
50 |
Maquet Cardiovascular Us Sales, Llc |
II |
Jul-15-2015 |
51 |
Maquet Cardiovascular Us Sales, Llc |
I |
Jun-08-2015 |
52 |
Maquet Cardiovascular Us Sales, Llc |
I |
Jul-06-2012 |
53 |
Mindray DS USA, Inc. d.b.a. Mindray North America |
I |
Nov-16-2012 |
54 |
Mindray DS USA, Inc. dba Mindray North America |
II |
Sep-04-2024 |
55 |
Mindray DS USA, Inc. dba Mindray North America |
II |
Mar-02-2018 |
56 |
Mindray DS USA, Inc. dba Mindray North America |
II |
Aug-30-2016 |
57 |
Mindray DS USA, Inc., dba Datascope Patient Monitoring |
II |
Apr-08-2010 |
58 |
Penlon, Ltd. |
II |
Mar-26-2012 |
59 |
Philips Healthcare Inc. |
II |
Aug-24-2010 |
60 |
Spacelabs Healthcare, Llc |
II |
Dec-27-2010 |
61 |
Spacelabs Healthcare, Llc |
II |
Jul-29-2010 |
62 |
Spacelabs Healthcare, Ltd. |
I |
Nov-21-2017 |
|
|
|
|