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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)
Feb 6, 2024Getinge Usa Sales Inc
Flow-c Anesthesia System, model 6887700
Open, Classified
BSZK133958
Feb 6, 2024Getinge Usa Sales Inc
Flow-i C40 Anesthesia System, model 6677400
Open, Classified
BSZK133958
Feb 6, 2024Getinge Usa Sales Inc
Flow-i C30 Anesthesia System, model 6677300
Open, Classified
BSZK133958
Feb 6, 2024Getinge Usa Sales Inc
Flow-i C20 Anesthesia System, model 6677200
Open, Classified
BSZK133958
Feb 1, 2024Draegerwerk Ag & Co. Kgaa
Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
Open, Classified
BSZK230931
Jan 26, 2023Getinge Usa Sales Inc
Getinge Flow-e Anesthesia System, Part No. 6887900
Open, Classified
BSZK191027
Jan 26, 2023Getinge Usa Sales Inc
Getinge Flow-c Anesthesia System, Part No. 6887700
Open, Classified
BSZK191027
Jan 26, 2023Getinge Usa Sales Inc
Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
Open, Classified
BSZK191027
Dec 7, 2022Getinge Usa Sales Inc
Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
Open, Classified
BSZK191027
Jul 19, 2022GE Healthcare, LLC
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Terminated
BSZK172045
Jun 23, 2022Getinge Usa Sales Inc
Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
Terminated
BSZK191027
Jun 23, 2022Getinge Usa Sales Inc
Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
Terminated
BSZK191027
May 27, 2022GE Healthcare, LLC
GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.
Open, Classified
BSZK172045
Apr 25, 2022GE Healthcare, LLC
Field replacement back up batteries distributed on or after April 1, 2019 for Avance CS2, Avance CS2 Pro, Avance, Amingo, Aespire View anesthesia devices
Open, Classified
BSZK172045
Apr 25, 2022GE Healthcare, LLC
Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
Open, Classified
BSZK172045
Dec 16, 2021Draeger Medical, Inc.
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
Terminated
BSZK072884
Dec 9, 2021Getinge Usa Sales Inc
Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 0
Open, Classified
BSZK191027
Aug 2, 2021GE Healthcare, LLC
Flow sensors that may be installed in the following GEHC anesthesia machines: (1) Aestiva MRI, GTIN 0080682102339; (2) Aestiva 7900; (3) Aestiva 7100; (4) Aespire System Carestation, S/5 Protiva Conf
Open, Classified
BSZK172045
Aug 2, 2021GE Healthcare, LLC
Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF
Open, Classified
BSZK172045
Jan 29, 2021Getinge Group Logistics America, LLC
Anesthesia gas-machine - Product Usage: intended for use in administering anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients
Terminated
BSZK191027
Sep 17, 2020GE Healthcare, LLC
Flow Sensor Service Part, Catalog 2096513-001-S
Open, Classified
BSZNone listed
Sep 17, 2020GE Healthcare, LLC
Flow Sensor Service Part, Catalog 2087640-001-S
Open, Classified
BSZNone listed
Sep 17, 2020GE Healthcare, LLC
Flow Sensor Service Part, Catalog 2089610-001-S
Open, Classified
BSZNone listed
Sep 17, 2020GE Healthcare, LLC
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Open, Classified
BSZK172045
Sep 17, 2020GE Healthcare, LLC
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The d
Open, Classified
BSZK172045
Sep 17, 2020GE Healthcare, LLC
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The de
Open, Classified
BSZK172045
Sep 17, 2020GE Healthcare, LLC
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability t
Open, Classified
BSZK172045
Jan 23, 2020GE Healthcare, LLC
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
Terminated
BSZNone listed
Jan 23, 2020GE Healthcare, LLC
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
Terminated
BSZK151570
Jul 19, 2019GE Healthcare, LLC
Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7. 1006-9321-000-007639 8. 1006-9321-000-000023 9. 1006-9321
Terminated
BSZK000706
Jul 19, 2019GE Healthcare, LLC
Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-009857 6. 1009-9003-000 7. 1009-9000-000-008120 8. 1009-9000-00
Terminated
BSZK000706
Jul 19, 2019GE Healthcare, LLC
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-
Terminated
BSZK050055
Nov 9, 2018GE Healthcare, LLC
Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN
Terminated
BSZK110213
K170872
Nov 9, 2018GE Healthcare, LLC
Aisys CS2 Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR U
Terminated
BSZK110213
K170872
Nov 9, 2018GE Healthcare, LLC
Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA,
Terminated
BSZK110213
K170872
Jul 24, 2018GE Medical Systems China Co., Ltd.
GE 9100c NXT anesthesia systems
Terminated
BSZK151570
Jul 24, 2018GE Medical Systems China Co., Ltd.
GE Carestation 30 anesthesia systems
Terminated
BSZK151570
Jul 24, 2018GE Medical Systems China Co., Ltd.
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Terminated
BSZK151570
May 24, 2018Draeger Medical, Inc.
Perseus A500 Anesthesia Machine; Cat. no. MK06000 Product V Product Usage: Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pres
Terminated
BSZK133886
May 24, 2018Draeger Medical, Inc.
Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases a
Terminated
BSZK081447
May 24, 2018Draeger Medical, Inc.
Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by
Terminated
BSZK072884
May 24, 2018Draeger Medical, Inc.
Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied b
Terminated
BSZK042419
May 24, 2018Draeger Medical, Inc.
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplie
Terminated
BSZK042419
May 8, 2018Draeger Medical, Inc.
Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O
Terminated
BSZK042419
May 8, 2018Draeger Medical, Inc.
Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O,
Terminated
BSZK042419
May 8, 2018Draeger Medical, Inc.
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2,
Terminated
BSZK042419
May 8, 2018Draeger Medical, Inc.
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, a
Terminated
BSZK072884
Nov 21, 2017Spacelabs Healthcare, Ltd.
Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment
Terminated
BSZK113051
Oct 11, 2017GE Medical Systems China Co., Ltd.
Carestation 620 A2, Carestation 650 A2, and Carestation 650c A2
Open, Classified
BSZNone listed
Oct 11, 2017GE Medical Systems China Co., Ltd.
Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
Open, Classified
BSZK151570

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