Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ph manufacturing sdn bhd - euterpe oleracea -

Ireland - English - HPRA (Health Products Regulatory Authority)

clonmel healthcare ltd - pantoprazole sodium sesquihydrate - gastro-resistant tablet - 20 milligram(s) - proton pump inhibitors; pantoprazole

Australia - English - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd -

Australia - English - Department of Health (Therapeutic Goods Administration)

draeger australia pty ltd - 36898 - patient monitor module, blood gas, transcutaneous - for the continuous non-invasive measurement of the body's ability to deliver oxygen to tissue and remove carbon dioxide via the cardiopulmonary system. transcutaneous monitoring is useful in trending the patient's oxygenation status and can reduce the number of blood gas samples needed. however it is not intended to replace invasive blood gas monitoring via a blood gas device.

Australia - English - Department of Health (Therapeutic Goods Administration)

philips electronics australia ltd - 38473 - information system, patient record - the information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic/ hemodynamic, clinical, medical image and other related data. the system is capable of processing/analyzing information, such as multi?channel ecg signals, and performing other data management functions, such as creating reports.

Australia - English - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 10980 - computer, cardiac catheterization laboratory - the device is intended for complete physiological/ hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. the device is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. the device is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed. user-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses. use of the system is not intended for unattended patient monitoring or in situations where arrhythmia detection is required.

Australia - English - Department of Health (Therapeutic Goods Administration)

seer medical holdings ltd - 58884 - self-care monitoring web-based application software - the 'seer app: epilepsy management' allows for the recording of events such as seizures, dizziness, and moods. these recorded events will be integrated along with other data such as medication timing, environmental, sleep, and other sensor data from the mobile device and/or connected wearables. the app can then display event trending, alerts, recommendations, and risk assessment to the person based on extrapolated historical patterns, such as seizure cycles.

Australia - English - Department of Health (Therapeutic Goods Administration)

philips electronics australia ltd - 38473 - information system, patient record - intended for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic/hemodynamic, clinical, medical image and other related data.

Singapore - English - HSA (Health Sciences Authority)

masimo asia pacific pte. ltd. - general hospital - indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rso2) in the tissue under the sensors in patients in healthcare environments. the system is only to be used with masimo o3 sensors. when used with the o3 adult sensor, the system is for measuring absolute and trending rso2 on cerebral sites and trending rso2 on non-cerebral sites in adults ≥40kg. when used with the o3 pediatric sensor, the system is for measuring absolute and trending rso2 on cerebral sites and trending rso2 on non-cerebral sites in pediatrics ≥5kg and <40kg. when used with the o3 neonatal sensor, the system is for measuring only trending rso2 on cerebral sites and trending rso2 on non-cerebral sites in neonates <10kg. it is also indicated for the monitoring of the relative hemoglobin changes of oxygenated hemoglobin (Δo2hb), deoxygenated hemoglobin (Δhhb), and total hemoglobin (Δchb) as measured from the masimo o3 sensor when applied to the cerebral tissue in adults.

United States - English - NLM (National Library of Medicine)

rare disease therapeutics, inc - pit viper (crotalinae) immune globulin antivenin (equine) (unii: 92vv7g83ed) (pit viper (crotalinae) immune globulin antivenin (equine) - unii:92vv7g83ed) - pit viper (crotalinae) immune globulin antivenin (equine) 24 mg in 1 ml - anavip [crotalidae immune f(ab')2 (equine)] is an equine-derived antivenin indicated for the management of adult and pediatric patients with north american pit viper envenomation.