Newport Medical Instruments, Inc.
Newport Medical Instruments, Inc. holds FDA 510(k) medical device clearances, first cleared 1982, most recent 2012, with 3 FDA device recalls on record.
Top product codes for Newport Medical Instruments, Inc.
FDA recalls by Newport Medical Instruments, Inc.
- Z-1874-2017 — Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
- Z-1171-2013 — Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces.
- Z-2250-2012 — Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs.). The HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
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 Newport Medical Instruments, Inc.
- K121891 — NEWPORT AURA VENTILATOR
- K111146 — NEWPORT HT70 VENTILATOR
- K101803 — NEWPORT E360 VENTILATOR
- K090888 — NEWPORT HT70 FAMILY OF VENTILATORS
- K082724 — NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
- K061094 — NEWPORT E500 WAVE VENTILATOR
- K053502 — NEWPORT E360 VENTILATOR
- K041082 — NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER
- K030780 — NEWPORT E500 WAVE VENTILATOR
- K992133 — NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL
- K972833 — E100M VENTILATOR (E100M)
- K941308 — NEWPORT ELECTRONIC MANOMETER
- K940739 — NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR
- K941309 — NEWPORT ELECTRONIC MANOMETER
- K931542 — NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
- K901785 — NEWPORT WAVE VENTILATOR MODEL E200
- K883809 — NEWPORT VENTILATOR MODEL E150
- K860373 — THE M100 AIR/OXYGEN MIXER
- K860438 — NEWPORT VENTILATOR MODEL E-100
- K852108 — NEWPORT VENTILATOR MODEL E-100
- K844350 — NEWPORT VENTILATOR MODEL E-100
- K820746 — NEWPORT VENTILATOR MODEL E100
Data sourced from openFDA. This site is unofficial and independent of the FDA.