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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)
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Top companies in BSZ

DateFirm and productCodeLinked 510(k)
Oct 4, 2017GE Healthcare, LLC
DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be used to deliver anesthetic agent.
Terminated
BSZK170872
Jul 14, 2017Mindray 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
BSZK151954
Jul 14, 2017Mindray 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
BSZK123211
May 24, 2017GE Healthcare, LLC
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Terminated
BSZK151570
Apr 14, 2017Del 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
BSZK113051
Nov 3, 2016GE Healthcare, LLC
GE Healthcare, Avance, Avance CS2, Amingo.
Terminated
BSZK112722
K131945
Aug 4, 2016Beckman 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
BSZK140911
K151954
Jun 15, 2016Mindray 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
BSZK151954
Mar 15, 2016GE 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
BSZK110213
K132530
Feb 22, 2016Maquet 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
BSZK133958
Feb 17, 2016GE Medical Systems, LLC
GE Healthcare, Aisys Carestation.
Terminated
BSZK110213
Feb 17, 2016GE Medical Systems, LLC
GE Healthcare, Aisys CS2 anesthesia..
Terminated
BSZK132530
Jan 21, 2016GE 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
BSZNone listed
Jan 21, 2016GE 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
BSZK112722
K131945 +1
Jan 21, 2016GE 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
BSZK110213
Jan 21, 2016GE 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
BSZK050055
Jan 21, 2016GE 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
BSZK122445
K143530
Dec 12, 2015Draeger 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
BSZK133886
Jul 27, 2015Draeger 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
BSZK072884
Jul 15, 2015Maquet 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
BSZK133958
Jun 8, 2015Maquet 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
BSZK133958
Apr 2, 2015GE 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
BSZK122445
Mar 5, 2014MCKESSON 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
BSZK113633
Nov 20, 2013Del 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
BSZK003251
K010850
Oct 15, 2013GE Healthcare, LLC
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
Terminated
BSZK110213
K112722 +1
Oct 15, 2013GE Healthcare, LLC
GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
Terminated
BSZK110213
K111116 +3
Oct 10, 2013Draeger 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
BSZK042419
Sep 6, 2013GE 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
BSZK000275
K925580
Jun 3, 2013GE 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
BSZK090892
K110213 +3
Dec 19, 2012Del 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
BSZK003251
Nov 16, 2012Mindray 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
BSZK102471
Nov 16, 2012Mindray 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
BSZK102471
Oct 9, 2012Accutron 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
BSZK052335
Oct 9, 2012Accutron Inc
CM Flowmeter Pkg H, Model #36700, Serial # 13749 Product Usage: Conscious Sedation Unit Analgesia Gas Machine.
Terminated
BSZK052335
Oct 9, 2012Accutron 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
BSZK052335
Oct 9, 2012Accutron 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
BSZK052335
Jul 6, 2012Maquet 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
BSZK112114
Mar 26, 2012Penlon, 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
BSZK061102
Dec 27, 2010Spacelabs 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
BSZK051629
Oct 6, 2010GE Healthcare, LLC
GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Terminated
BSZK081844
Oct 6, 2010GE Healthcare, LLC
GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Terminated
BSZK081844
Oct 6, 2010GE Healthcare, LLC
GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Terminated
BSZK090233
Sep 23, 2010Draeger 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
BSZK042419
Sep 23, 2010Draeger 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
BSZK042419
Aug 24, 2010Philips Healthcare Inc.
Philips M1026BT Gas Modules with manifolds
Terminated
BSZK040917
Aug 24, 2010Philips Healthcare Inc.
Philips M1026B IntelliVue Anesthesia Gas Modules with manifolds
Terminated
BSZK040917
Aug 24, 2010Philips Healthcare Inc.
Philips M1019A IntelliVue G5 Anesthesia Gas Modules with manifolds
Terminated
BSZK060541
Aug 24, 2010Philips Healthcare Inc.
Philips M1013A IntelliVue G1 Anesthesia Gas Modules with manifolds
Terminated
BSZK060541
Jul 29, 2010Spacelabs 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
BSZK051629
May 11, 2010Ge Healthcare, Llc
GE, 1009-9002-000 Avance Anesthesia Machine and Monitor
Terminated
BSZK081844

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