|
|
| 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 |
II |
Feb-06-2024 |
| 43 |
Getinge Usa Sales Inc |
I |
Jan-26-2023 |
| 44 |
Getinge Usa Sales Inc |
II |
Dec-07-2022 |
| 45 |
Getinge Usa Sales Inc |
I |
Jun-23-2022 |
| 46 |
Getinge Usa Sales Inc |
I |
Jan-10-2022 |
| 47 |
MCKESSON TECHNOLOGIES INC. |
I |
Mar-05-2014 |
| 48 |
Maquet Cardiovascular Us Sales, Llc |
I |
Feb-22-2016 |
| 49 |
Maquet Cardiovascular Us Sales, Llc |
II |
Jul-15-2015 |
| 50 |
Maquet Cardiovascular Us Sales, Llc |
I |
Jun-08-2015 |
| 51 |
Maquet Cardiovascular Us Sales, Llc |
I |
Jul-06-2012 |
| 52 |
Mindray DS USA, Inc. d.b.a. Mindray North America |
I |
Nov-16-2012 |
| 53 |
Mindray DS USA, Inc. dba Mindray North America |
II |
Mar-02-2018 |
| 54 |
Mindray DS USA, Inc. dba Mindray North America |
II |
Aug-30-2016 |
| 55 |
Mindray DS USA, Inc., dba Datascope Patient Monitoring |
II |
Apr-08-2010 |
| 56 |
Penlon, Ltd. |
II |
Mar-26-2012 |
| 57 |
Philips Healthcare Inc. |
II |
Aug-24-2010 |
| 58 |
Spacelabs Healthcare, Llc |
II |
Dec-27-2010 |
| 59 |
Spacelabs Healthcare, Llc |
II |
Jul-29-2010 |
| 60 |
Spacelabs Healthcare, Ltd. |
I |
Nov-21-2017 |
|
|
|
|
