Ohmeda Medical
Ohmeda Medical holds FDA 510(k) medical device clearances, first cleared 1984, most recent 2013, with 13 FDA device recalls on record.
Top product codes for Ohmeda Medical
FDA recalls by Ohmeda Medical
10 most recent of 13- Z-0041-2020 — Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
- Z-1181-2018 — Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.
- Z-1507-2017 — Giraffe Bedded Warmer, Panda Warmer Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
- Z-1505-2017 — Giraffe Incubator Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
- Z-1502-2017 — Giraffe Incubator The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed temperature controlled environment
- Z-1509-2017 — Giraffe OmniBed Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment
- Z-1506-2017 — Giraffe Bedded Warmer, Panda Warmer Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
- Z-1503-2017 — Giraffe Spot PT Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital
- Z-1501-2017 — Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the Giraffe OmniBed, incubators and warmers except for Panda and Giraffe Warmers. It is not intended for use to support surgical field lighting.
- Z-1504-2017 — Giraffe OmniBed Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperatures controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
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 Ohmeda Medical
1–100 of 120- K123309 — GIRAFFE AND PANDA WARMERS
- K101778 — GIRAFFE INCUBATOR
- K101788 — GIRAFFE OMNIBED
- K090697 — MODIFICATION TO: GIRAFFE AND PANDA WARMER
- K072157 — MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
- K070377 — GIRAFFE AND PANDA WARMER
- K070210 — GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM
- K070247 — GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM
- K040068 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
- K020543 — OHMEDA MEDICAL GIRAFFE OMNIBED
- K020547 — OHMEDA MEDICAL GIRAFFE INCUBATOR
- K010388 — SONDREX P.A.L. SYSTEM
- K011549 — OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
- K010222 — OHMEDA MEDICAL GIRAFFE INCUBATOR
- DEN000001 — OHMEDA INOVENT DELIVERY SYSTEM
- K993407 — OHMEDA MEDICAL OMNIBED
- K993712 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
- K973896 — OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
- K974349 — OHMEDA-OHIO CARE PLUS INCUBATOR
- K974083 — CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
- K974374 — SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV
- K971243 — OHMEDA INFANT RESUSCITATION SYSTEM
- K965041 — OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
- K962648 — OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
- K962127 — OHMEDA 3800 PULSE OXIMETER
- K946127 — OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
- K963058 — INFANT WARMER SYSTEM
- K960964 — OHMEDA 7900 ANESTHESIA VENTILATOR
- K962806 — OHMEDA-OHIO CAE PLUS INCUBATOR
- K944052 — RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR
- K942091 — OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE
- K935090 — CUFF-CATH
- K931304 — OHMEDA HAND HELD OXIMETER
- K943360 — OHIO CARE PLUS INCUBATOR
- K935782 — DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
- K941428 — EXACTA PERCUTANEOUS INTRODUCER SHEATH
- K936182 — CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT
- K935274 — DIPRIVAN LUER CONNECTOR
- K931439 — OHMEDA MODEL 5330 ANESTHETIC MONITOR
- K921742 — OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
- K930866 — RASCAL II
- K921766 — OHIO INFANT WARMER SYSTEM
- K920622 — RASCAL II
- K913593 — OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER
- K920590 — OHMEDA MODEL 5250 RGM MONITOR
- K910571 — BILIBLANKET LIGHT METER
- K910929 — OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V.
- K914487 — OHIO CARE PLUS INCUBATOR
- K913154 — OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
- K911193 — OHMEDA MODEL 4700 OXICAP
- K905635 — OHMEDA MODULUS CD ANESTHESIA SYSTEM
- K910847 — OHMEDA 7810 ANESTHESIA VENTILATOR
- K910316 — OHMEDA - LOW FLOW FLOWMETER
- K902084 — OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
- K901117 — OHMEDA UNIVERSAL PAC
- K901846 — OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
- K901585 — OHMEDA - OHIO(R) CARE PLUS INCUBATOR
- K901119 — OHMEDA MODULUS CD ANESTHESIA SYSTEM
- K893780 — OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM
- K896023 — OHMEDA 9000 SYRINGE PUMP
- K894309 — OHMEDA MODULUS CD ANESTHESIA SYSTEM
- K894129 — BILIBLANKET PHOTOTHERAPY DEVICE
- K884793 — ADVENT VENTILATOR
- K883159 — OHMEDA 7800 ANESTHESIA VENTILATOR
- K892057 — OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
- K890606 — OHMEDA 5330 AGENT MONITOR
- K890410 — REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE
- K884463 — CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
- K884160 — OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
- K883229 — OHMEDA CONTINUOUS SUCTION REGULATOR
- K883415 — VASCULON 2 INTRAVENOUS CANNULA
- K881767 — VIGGO INSUFLON
- K882743 — OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
- K880830 — SENTORR ARTERIAL PRESSURE SENSOR
- K882489 — REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
- K881758 — VIGGO VASCUPORT NEEDLE
- K880572 — OHMEDA 2350 FINAPRES(R) BLOOD PRESSURE MONITOR
- K881614 — MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
- K880054 — CPU 1100 VENTILATOR
- K875350 — OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
- K875225 — UMBILICAL ARTERY OXYGEN SENSOR
- K873199 — OHMEDA 4700 OXICAP MONITOR
- K874104 — OHMEDA BIOX 3760 PULSE OXIMETER
- K872772 — OHMEDA BIOX 3740 PULSE OXIMETER
- K871399 — OHIO(R) CARE PLUS INCUBATOR
- K871398 — CPU-1 INTENSIVE CARE VENTILATOR
- K864900 — VIGGO EXACTA PRESSURE MONITORING KIT
- K870261 — VIGGO EXACTA PRESSURE MONITORING SYSTEM
- K861987 — 2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF
- K863959 — OHMEDA 6000 MULTI-GAS MONITOR
- K864536 — OHMEDA 5500 AIRWAY PRESSURE MONITOR
- K864129 — OHMEDA 7400 ANESTHESIA VENTILATOR
- K863207 — OHMEDA 'B' SERIES GAS DELIVERY SYSTEM
- K863208 — OHMEDA AUXILIARY POWER SYSTEM
- K863546 — CPU GRAPH
- K862687 — OHMEDA 5410 VOLUME MONITOR
- K862688 — OHMEDA 5420 VOLUME MONITOR
- K862831 — MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
- K861261 — OHMEDA POSI-PULSE SUCTION UNIT
- K861397 — OHMEDA 5300 ANESTHETIC AGENT MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.