Datex-Ohmeda, Inc.
Datex-Ohmeda, Inc. holds FDA 510(k) medical device clearances, first cleared 1998, most recent 2026, with 26 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 26- 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.
- Z-0075-2025 — Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
- Z-0081-2025 — Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
- Z-0080-2025 — Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
- Z-0078-2025 — Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
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.