Panels › Anesthesiology › Product code BSZ · Class 2
Gas-Machine, Anesthesia
Regulation 868.5160
2510(k)s in 12 months (189 all time)
12recalls in 12 months (177 all time)
161recalls that name a 510(k)
Top companies in BSZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2017 | GE Healthcare, LLC DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE
Cassettes are intended to be used to deliver anesthetic agent. Terminated |
BSZ | K170872 |
| Jul 14, 2017 | Mindray DS USA, Inc. dba Mindray North America A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7)
Product Usage:
The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a Terminated |
BSZ | K151954 |
| Jul 14, 2017 | Mindray DS USA, Inc. dba Mindray North America A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5)
Product Usage:
The A-Series Anesthesia System is a device used to administer to a patient, contin Terminated |
BSZ | K123211 |
| May 24, 2017 | GE Healthcare, LLC Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 Terminated |
BSZ | K151570 |
| Apr 14, 2017 | Del Mar Reynolds Medical, Ltd. Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room.
Absorber Adapter Assembly Service Kit, part number: 050-9045-00.
Absorber Ad Terminated |
BSZ | K113051 |
| Nov 3, 2016 | GE Healthcare, LLC GE Healthcare, Avance, Avance CS2, Amingo. Terminated |
BSZ | K112722 K131945 |
| Aug 4, 2016 | Beckman Coulter Inc. UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222
UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer Terminated |
BSZ | K140911 K151954 |
| Jun 15, 2016 | Mindray DS USA, Inc. dba Mindray North America A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA Terminated |
BSZ | K151954 |
| Mar 15, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys and Aisys CS2.
Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (neonatal, pediatric, and adult). Terminated |
BSZ | K110213 K132530 |
| Feb 22, 2016 | Maquet Cardiovascular Us Sales, Llc Flow-i Anesthesia System
Product Usage:
The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to Terminated |
BSZ | K133958 |
| Feb 17, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys Carestation. Terminated |
BSZ | K110213 |
| Feb 17, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys CS2 anesthesia.. Terminated |
BSZ | K132530 |
| Jan 21, 2016 | GE Medical Systems, LLC Anesthesia device service kits.
ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000
ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000
ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000
ASSY-MSN, VENT ENGIN Terminated |
BSZ | None listed |
| Jan 21, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys CS2,1011-9050-000;
Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000.
The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and v Terminated |
BSZ | K112722 K131945 +1 |
| Jan 21, 2016 | GE Medical Systems, LLC GE Healthcare, Aisys, 1011-9000-000.
The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pe Terminated |
BSZ | K110213 |
| Jan 21, 2016 | GE Medical Systems, LLC GE Healthcare, Aestiva MRI, 1006-9310-000.
This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlle Terminated |
BSZ | K050055 |
| Jan 21, 2016 | GE Medical Systems, LLC GE Healthcare, Aespire 7900, 1009-9012-000 &
Aespire View, 1009-9212-000.
The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to Terminated |
BSZ | K122445 K143530 |
| Dec 12, 2015 | Draeger Medical, Inc. Perseus A500 Anesthesia Workstation, MK06000.
Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous bre Terminated |
BSZ | K133886 |
| Jul 27, 2015 | Draeger Medical, Inc. Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms. Terminated |
BSZ | K072884 |
| Jul 15, 2015 | Maquet Cardiovascular Us Sales, Llc The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847
FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire Terminated |
BSZ | K133958 |
| Jun 8, 2015 | Maquet Cardiovascular Us Sales, Llc FLOW-i Anesthesia System
The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations. Terminated |
BSZ | K133958 |
| Apr 2, 2015 | GE Healthcare GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers 1009-9012-000.
Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients Terminated |
BSZ | K122445 |
| Mar 5, 2014 | MCKESSON TECHNOLOGIES INC. McKesson Anesthesia Care
Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which th Terminated |
BSZ | K113633 |
| Nov 20, 2013 | Del Mar Reynolds Medical, Ltd. CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, Terminated |
BSZ | K003251 K010850 |
| Oct 15, 2013 | GE Healthcare, LLC GE Healthcare, Aisys, Amingo, Avance, and Avance CS2.
Intended for volume or pressure control ventilation. Terminated |
BSZ | K110213 K112722 +1 |
| Oct 15, 2013 | GE Healthcare, LLC GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom.
Intended for volume or pressure control ventilation. Terminated |
BSZ | K110213 K111116 +3 |
| Oct 10, 2013 | Draeger Medical, Inc. Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M
Product Usage:
used to administer anesthesia and ventilation to patients during surgical procedures. Terminated |
BSZ | K042419 |
| Sep 6, 2013 | GE Healthcare, LLC Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane Terminated |
BSZ | K000275 K925580 |
| Jun 3, 2013 | GE Healthcare, LLC Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850.
Intended to provide general inhalation anesthesia and ventilatory support. Terminated |
BSZ | K090892 K110213 +3 |
| Dec 19, 2012 | Del Mar Reynolds Medical, Ltd. BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine.
In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. I Terminated |
BSZ | K003251 |
| Nov 16, 2012 | Mindray DS USA, Inc. d.b.a. Mindray North America Mindray A5 Anesthesia Delivery System
Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430
This is a device used to administer to a patient continuously or intermi Terminated |
BSZ | K102471 |
| Nov 16, 2012 | Mindray DS USA, Inc. d.b.a. Mindray North America Mindray A3 Anesthesia Delivery System
Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430
This is a device used to administer to a patient continuously or inter Terminated |
BSZ | K102471 |
| Oct 9, 2012 | Accutron Inc Newport Portable Package, Model #50000, Serial #
13591, 13592, 13604, 13606, 13614, 13662, 13663, 13664, 13726, 13731, 13733, 13736, 13737, 13738, 13740, 13768, 13770, 13771, 13772, 13784, 13787.
Terminated |
BSZ | K052335 |
| Oct 9, 2012 | Accutron Inc CM Flowmeter Pkg H, Model #36700, Serial #
13749
Product Usage:
Conscious Sedation Unit Analgesia Gas Machine. Terminated |
BSZ | K052335 |
| Oct 9, 2012 | Accutron Inc Ultra PC% Cabinet Mount Package G, Model #36600,
Serial # 13593, 13594, 13595, 13596, 13597, 13598, 13599, 13600, 13602, 13605, 13610, 13611, 13612, 13615, 13616, 13617, 13621, 13622, 13624, 13625, 1 Terminated |
BSZ | K052335 |
| Oct 9, 2012 | Accutron Inc Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793.
Flowmeter, CM Assembly, Model#31970, Serial#13692.
Product Usage:
Conscious Sedation Unit Analgesia Gas Machine. Terminated |
BSZ | K052335 |
| Jul 6, 2012 | Maquet Cardiovascular Us Sales, Llc FLOW-I Anesthesia System
The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patient Terminated |
BSZ | K112114 |
| Mar 26, 2012 | Penlon, Ltd. Anesthesia Machines (digital display assembly);
A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maint Terminated |
BSZ | K061102 |
| Dec 27, 2010 | Spacelabs Healthcare, Llc Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaestheti Terminated |
BSZ | K051629 |
| Oct 6, 2010 | GE Healthcare, LLC GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland Terminated |
BSZ | K081844 |
| Oct 6, 2010 | GE Healthcare, LLC GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland Terminated |
BSZ | K081844 |
| Oct 6, 2010 | GE Healthcare, LLC GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland Terminated |
BSZ | K090233 |
| Sep 23, 2010 | Draeger Medical Systems, Inc. Fabius Tiro Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969
Compact anesthesia system that offers the full spectrum of anesthesia ventilation to military Terminated |
BSZ | K042419 |
| Sep 23, 2010 | Draeger Medical Systems, Inc. Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969
inhalation anesthesia machine for use in operating, induction and recovery rooms Terminated |
BSZ | K042419 |
| Aug 24, 2010 | Philips Healthcare Inc. Philips M1026BT Gas Modules with manifolds Terminated |
BSZ | K040917 |
| Aug 24, 2010 | Philips Healthcare Inc. Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds Terminated |
BSZ | K040917 |
| Aug 24, 2010 | Philips Healthcare Inc. Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds Terminated |
BSZ | K060541 |
| Aug 24, 2010 | Philips Healthcare Inc. Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds Terminated |
BSZ | K060541 |
| Jul 29, 2010 | Spacelabs Healthcare, Llc BleaseSirius Anaesthesia System, gas machine. Blease Beech House, Chiltern Court Asheridge Road, Chesham, Bucks HP5 2PX, England
Intended for use in the hospital environment and operating room. Terminated |
BSZ | K051629 |
| May 11, 2010 | Ge Healthcare, Llc GE, 1009-9002-000 Avance Anesthesia Machine and Monitor Terminated |
BSZ | K081844 |
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