Datex-Ohmeda, Inc.
Datex-Ohmeda, Inc. holds FDA 510(k) medical device clearances, first cleared 1998, most recent 2026, with 30 FDA device recalls on record.
Name variants for Datex-Ohmeda, Inc.
as filed with FDA- Datex-Ohmeda, Inc.
- Datex Ohmeda, Inc.
Top product codes for Datex-Ohmeda, Inc.
FDA recalls by Datex-Ohmeda, Inc.
10 most recent of 30- Z-3191-2026 — Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
- Z-3192-2026 — Et Control, Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents, Field replaceable unit (FRU) part numbers: 1011-8000-000-S, 5700665
- Z-3190-2026 — Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
- Z-3189-2026 — Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
- Z-2357-2026 — Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance
- Z-2358-2026 — Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
- Z-2359-2026 — Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
- Z-0048-2025 — GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
- Z-0047-2025 — GE Heathcare Giraffe OmniBed; neo natal incubator
- Z-0079-2025 — Amingo. OUS only.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Datex-Ohmeda, Inc.
- K254036 — Novii+ Wireless Patch System
- K260326 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
- K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)
- K213867 — Carestation 750/750c
- K213551 — Giraffe Omnibed Carestation CS1
- K213553 — Giraffe Incubator Carestation CS1
- K210384 — CARESCAPE R860
- K172702 — Tec 820, Tec 850
- K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
- K170872 — Aisys CS2
- K151570 — Carestation 620/650/650C
- K142679 — CARESCAPE R860
- K143530 — Aespire View
- K140575 — ENGSTROM CARESTATION, ENGSTROM PRO
- K132530 — GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
- K123125 — GE DATEX-OHMEDA AVANCE CS2
- K112722 — GE DATEX-OHMEDA AVANCE
- K110213 — GE DATEX-OHMEDA AISYS
- K090233 — GE DATEX-OHMEDA AISYS
- K081842 — ENGSTROM CARESTATION, ENGSTROM PRO
- K081844 — GE DATEX-OHMEDA AVANCE
- K073707 — GE DATEX-OHMEDA AISYS
- K072512 — MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
- K062710 — GE DATEX-OHMEDA ENGSTROM CARESTATION
- K061609 — GE DATEX-OHMEDA AISYS
- K060862 — GE DATEX-OHMEDA ENGSTROM CARESTATION
- K051895 — GE DATEX-OHMEDA ENGSTROM CARESTATION
- K050860 — GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
- K050676 — GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
- K050597 — GE DATEX-OHMEDA ENGSTROM CARESTATION
- K050626 — GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
- K043120 — MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
- K050055 — GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
- K041775 — GE DATEX-OHMEDA ENGSTROM CARESTATION
- K041524 — GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
- K040831 — DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
- K042154 — GE DATEX-OHMEDA AISYS CARESTATION
- K040743 — MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
- K031124 — POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR
- K023366 — DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
- K031027 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
- K031479 — AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506
- K021955 — TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES
- K012924 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
- K010463 — DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
- K002478 — S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
- K002878 — DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
- K002158 — S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
- K000647 — DATEX-OHMEDA NETWORK AND CENTRAL
- K001688 — DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
- K000892 — DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
- K000706 — DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
- K993410 — DATES-OHMEDA AESTIVA SMARTVENT MRI
- K993608 — DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
- K000275 — DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
- K993512 — DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
- K993656 — DATEX-OHMEDA TONOMETRY MODULE M-TONO
- K993296 — TRIP TONOMETRY CATHETER, 14F
- K992323 — DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
- K992181 — TRIP TONOMETRY CATHETER, 8F
- K990132 — DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
- K983684 — DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.