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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

Company510(k)sRecalls
Draeger Medical AG & Co. KG3723
Datex-Ohmeda2421
GE Healthcare041
GE Medical Systems China Co., Ltd.023
Ohmeda Medical170
Getinge Usa Sales Inc014
Mindray DS USA, Inc. dba Mindray North America09
GE Medical Systems, LLC08
Accutron, Inc.24
Maquet Critical Care AB51
Decided510(k)Device and applicantCode
Jun 25, 2026K253330A5 Anesthesia System (A5); A7 Anesthesia System (A7)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
BSZ
May 21, 2026K252746Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
Drägerwerk AG Co. Kgaa, DE
BSZ
Jul 11, 2025K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retro
Codonics.Incorporated
BSZ
Jul 23, 2023K230931Atlan
Drägerwerk AG Co. Kgaa, DE
BSZ
Mar 28, 2023K213867Carestation 750/750c
Datex-Ohmeda, Inc.
BSZ
Mar 26, 2021K201957A8, A9 Anesthesia System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
BSZ
Mar 18, 2020K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
Maquet Critical Care AB, SE
BSZ
Jan 12, 2018K171311A5 Anesthesia System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
BSZ
Jan 12, 2018K171292A7 Anesthesia System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
BSZ
Nov 3, 2017K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Av
Datex-Ohmeda, Inc.
BSZ
Aug 15, 2017K170872Aisys CS2
Datex-Ohmeda, Inc.
BSZ
Mar 29, 2017K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
Maquet Critical Care AB, SE
BSZ
Jan 21, 2016K151570Carestation 620/650/650C
Datex-Ohmeda, Inc.
BSZ
Oct 27, 2015K151954A7 Anesthesia System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
BSZ
Apr 24, 2015K143530Aespire View
Datex-Ohmeda, Inc.
BSZ
Jan 23, 2015K142552A7 Anesthesia System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd., CN
BSZ
Jan 5, 2015K140264MADM
Thornhill Research, Inc., CA
BSZ
Jul 1, 2014K132903DRE VENTURA
Dre Medical, Inc.
BSZ
Jun 20, 2014K133886PERSEUS A500
Draeger Medical GmbH
BSZ
May 9, 2014K131790A9800 ANESTHESIA WORKSTATION
Oricare, Inc.
BSZ
Mar 20, 2014K133958FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
Maquet Critical Care AB
BSZ
Dec 20, 2013K132530GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
Datex-Ohmeda, Inc.
BSZ
Aug 8, 2013K131945GE DATEX-OHMEDA AVANCE CS2
Datex-Ohmeda
BSZ
Aug 2, 2013K122063INTELLISAVE AX700 ANESTHESIA SYSTEM
Philips Anesthesia Care, DK
BSZ
Feb 14, 2013K123211A5 ANESTHESIA DELIVERY SYSTEM
Datascope Corp., Patient Monitoring Division
BSZ
Feb 6, 2013K123125GE DATEX-OHMEDA AVANCE CS2
Datex-Ohmeda, Inc.
BSZ
Oct 12, 2012K122445AESPIRE 7900, AESPIRE VIEW
Datex-Ohmeda
BSZ
Apr 20, 2012K113633MCKESSON ANESTHESIA CARE
Mckesson Technologies, Inc.
BSZ
Mar 28, 2012K103035SMARTPILOT VIEW MODEL MK04500
Draeger Medical GmbH
BSZ
Jan 26, 2012K120075AM-6000 ANESTHESIA MACHINE
Advanced Instrumentations, Inc.
BSZ
Jan 13, 2012K112114MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
Maquet Critical Care AB
BSZ
Dec 16, 2011K112722GE DATEX-OHMEDA AVANCE
Datex-Ohmeda, Inc.
BSZ
Jul 20, 2011K110213GE DATEX-OHMEDA AISYS
Datex-Ohmeda, Inc.
BSZ
Jun 10, 2011K102389NAVIGATOR APPLICATIONS SUITE
GE Healthcare Finland Oy
BSZ
May 9, 2011K102182MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
Maquet Critical Care AB
BSZ
Feb 11, 2011K102471AS3700 ANESTHSIA DELIVERY SYSTEM
Mindray DS USA, Inc.
BSZ
Feb 7, 2011K101439CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
Codonics, Inc.
BSZ
Jan 12, 2010K092864AESPIRE 7900, AESPIRE VIEW
Datex-Ohmeda Inc., A Division of Instrumentarium C
BSZ
Apr 30, 2009K090892GE DATEX-OHMEDA S/5 ADU CARESTATION
GE Healthcare Finland Oy
BSZ
Apr 1, 2009K083098NAVIGATOR APPLICATIONS SUITE
GE Healthcare Finland Oy
BSZ
Mar 5, 2009K090233GE DATEX-OHMEDA AISYS
Datex-Ohmeda, Inc.
BSZ
Dec 18, 2008K083413COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
Philips Medical Systems
BSZ
Oct 8, 2008K081447FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
Draeger Medical AG & Co. KG, DE
BSZ
Aug 29, 2008K081844GE DATEX-OHMEDA AVANCE
Datex-Ohmeda, Inc.
BSZ
Aug 7, 2008K081941NAVIGATOR APPLICATIONS SUITE
GE Healthcare Finland Oy
BSZ
Jul 30, 2008K072884FABIUS MRI
Draeger Medical AG & Co. KG
BSZ
Jun 9, 2008K080175NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
Datascope Corp., Patient Monitoring Division
BSZ
Jan 30, 2008K073707GE DATEX-OHMEDA AISYS
Datex-Ohmeda, Inc.
BSZ
Jan 22, 2008K072420MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
Oceanic Medical Products, Inc.
BSZ
Oct 10, 2007K071097NAVIGATOR APPLICATIONS SUITE
GE Healthcare Finland Oy
BSZ

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