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Datex-Ohmeda, Inc.

61 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1) (K260326)Datex-Ohmeda, Inc.2026-07-28
Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (K251663)Datex-Ohmeda, Inc.2025-10-22
Carestation 750/750c (K213867)Datex-Ohmeda, Inc.2023-03-28
Giraffe Omnibed Carestation CS1 (K213551)Datex Ohmeda, Inc.2022-03-02
Giraffe Incubator Carestation CS1 (K213553)Datex Ohmeda, Inc.2022-03-02
CARESCAPE R860 (K210384)Datex-Ohmeda, Inc.2021-11-04
Tec 820, Tec 850 (K172702)Datex-Ohmeda, Inc.2018-01-04
Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2 (K172045)Datex-Ohmeda, Inc.2017-11-03
Aisys CS2 (K170872)Datex-Ohmeda, Inc.2017-08-15
Carestation 620/650/650C (K151570)Datex-Ohmeda, Inc.2016-01-21
CARESCAPE R860 (K142679)Datex-Ohmeda, Inc.2015-06-12
Aespire View (K143530)Datex-Ohmeda, Inc.2015-04-24
ENGSTROM CARESTATION, ENGSTROM PRO (K140575)Datex-Ohmeda, Inc.2015-02-03
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) (K132530)Datex-Ohmeda, Inc.2013-12-20
GE DATEX-OHMEDA AVANCE CS2 (K123125)Datex-Ohmeda, Inc.2013-02-06
GE DATEX-OHMEDA AVANCE (K112722)Datex-Ohmeda, Inc.2011-12-16
GE DATEX-OHMEDA AISYS (K110213)Datex-Ohmeda, Inc.2011-07-20
GE DATEX-OHMEDA AISYS (K090233)Datex-Ohmeda, Inc.2009-03-05
ENGSTROM CARESTATION, ENGSTROM PRO (K081842)Datex-Ohmeda, Inc.2008-10-03
GE DATEX-OHMEDA AVANCE (K081844)Datex-Ohmeda, Inc.2008-08-29
GE DATEX-OHMEDA AISYS (K073707)Datex-Ohmeda, Inc.2008-01-30
MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) (K072512)Datex-Ohmeda, Inc.2007-10-03
GE DATEX-OHMEDA ENGSTROM CARESTATION (K062710)Datex-Ohmeda, Inc.2006-12-08
GE DATEX-OHMEDA AISYS (K061609)Datex-Ohmeda, Inc.2006-06-27
GE DATEX-OHMEDA ENGSTROM CARESTATION (K060862)Datex-Ohmeda, Inc.2006-06-05
GE DATEX-OHMEDA ENGSTROM CARESTATION (K051895)Datex-Ohmeda, Inc.2005-09-27
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR (K050860)Datex-Ohmeda, Inc.2005-06-21
GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) (K050676)Datex-Ohmeda, Inc.2005-04-12
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM (K050626)Datex-Ohmeda, Inc.2005-03-25
GE DATEX-OHMEDA ENGSTROM CARESTATION (K050597)Datex-Ohmeda, Inc.2005-03-25
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER (K043120)Datex-Ohmeda, Inc.2005-03-01
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM (K050055)Datex-Ohmeda, Inc.2005-02-04
GE DATEX-OHMEDA ENGSTROM CARESTATION (K041775)Datex-Ohmeda, Inc.2004-10-26
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM (K041524)Datex-Ohmeda, Inc.2004-09-20
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500 (K040831)Datex-Ohmeda, Inc.2004-09-02
GE DATEX-OHMEDA AISYS CARESTATION (K042154)Datex-Ohmeda, Inc.2004-08-31
MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM (K040743)Datex-Ohmeda, Inc.2004-04-22
POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR (K031124)Datex-Ohmeda, Inc.2003-12-04
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS (K023366)Datex-Ohmeda, Inc.2003-10-07
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) (K031027)Datex-Ohmeda, Inc.2003-06-26
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 (K031479)Datex-Ohmeda, Inc.2003-06-06
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES (K021955)Datex-Ohmeda, Inc.2002-10-08
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (K012924)Datex-Ohmeda, Inc.2002-01-30
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES (K010463)Datex-Ohmeda, Inc.2001-03-15
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 (K002478)Datex-Ohmeda, Inc.2000-10-05
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER (K002878)Datex-Ohmeda, Inc.2000-09-21
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE (K002158)Datex-Ohmeda, Inc.2000-09-06
DATEX-OHMEDA NETWORK AND CENTRAL (K000647)Datex-Ohmeda, Inc.2000-07-13
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER (K001688)Datex-Ohmeda, Inc.2000-06-30
DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES (K000892)Datex-Ohmeda, Inc.2000-06-16
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR (K000706)Datex-Ohmeda, Inc.2000-05-11
DATES-OHMEDA AESTIVA SMARTVENT MRI (K993410)Datex-Ohmeda, Inc.2000-04-25
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) (K993608)Datex-Ohmeda, Inc.2000-04-13
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA (K000275)Datex-Ohmeda, Inc.2000-04-12
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER (K993512)Datex-Ohmeda, Inc.2000-03-31
DATEX-OHMEDA TONOMETRY MODULE M-TONO (K993656)Datex-Ohmeda, Inc.2000-03-15
TRIP TONOMETRY CATHETER, 14F (K993296)Datex-Ohmeda, Inc.1999-12-15
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES (K992323)Datex-Ohmeda, Inc.1999-11-01
TRIP TONOMETRY CATHETER, 8F (K992181)Datex-Ohmeda, Inc.1999-08-24
DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC (K990132)Datex-Ohmeda, Inc.1999-01-21
DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS (K983684)Datex-Ohmeda, Inc.1998-11-06

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