Murilo Freitas – Página 28

Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Medical Devices: FDA Safety Communication

Murilo Freitas - 04:00, 16 de julio de 2023294

RoyalVibe Health, CellQuicken, and Well-Being Reality medical devices are not authorized for marketing and have not been shown to be safe or effective.

http://www.fda.gov/medical-devices/safety-communications/do-not-use-royalvibe-health-cellquicken-or-well-being-reality-ultrasound-medical-devices-fda-safety

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FDA Roundup: July 14, 2023

Murilo Freitas - 19:39, 13 de julio de 2023275

FDA Roundup: July 14, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-july-14-2023

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FDA Approves First Nonprescription Daily Oral Contraceptive

Murilo Freitas - 12:31, 12 de julio de 2023308

FDA Approves First Nonprescription Daily Oral Contraceptive
http://www.fda.gov/news-events/press-announcements/fda-approves-first-nonprescription-daily-oral-contraceptive

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NOxBOX Ltd. Recalls NOxBOXi Nitric Oxide System for Manifold Failure that May Cause Gas Leaks and Interrupt Therapy to Neonates

Murilo Freitas - 04:00, 12 de julio de 2023334

NOxBOXi delivers inhaled nitric oxide therapy to neonates. If the manifold fails, therapy may be interrupted and the patient may experience oxygen desaturation.

http://www.fda.gov/medical-devices/medical-device-recalls/noxbox-ltd-recalls-noxboxi-nitric-oxide-system-manifold-failure-may-cause-gas-leaks-and-interrupt

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Draeger Medical Recalls Oxylog 3000 Plus Emergency and Transport Ventilators for Risk of Unexpected Depleted Battery and Ventilator Stop

Murilo Freitas - 04:00, 12 de julio de 2023392

The Oxylog 3000 Plus battery may drain and stop providing required breathing support even when the ventilator is plugged into AC power.

http://www.fda.gov/medical-devices/medical-device-recalls/draeger-medical-recalls-oxylog-3000-plus-emergency-and-transport-ventilators-risk-unexpected

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FDA Roundup: July 11, 2023

Murilo Freitas - 19:16, 10 de julio de 2023327

FDA Roundup: July 11, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-july-11-2023

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UPDATE: Risk of Mortality Associated with Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease is No Longer Supported Based on Data and Analyses – Letter to Health Care Providers

Murilo Freitas - 04:00, 10 de julio de 2023273

Available data no longer supports a probable late mortality risk associated with paclitaxel-coated devices used to treat femoropopliteal disease.

http://www.fda.gov/medical-devices/letters-health-care-providers/update-risk-mortality-associated-paclitaxel-coated-devices-treat-peripheral-arterial-disease-no

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UPDATE: Paclitaxel-Coated Devices to Treat Peripheral Arterial Disease Unlikely to Increase Risk of Mortality – Letter to Health Care Providers

Murilo Freitas - 04:00, 10 de julio de 2023311

Available data no longer supports a probable late mortality risk associated with paclitaxel-coated devices used to treat femoropopliteal disease.

http://www.fda.gov/medical-devices/letters-health-care-providers/update-paclitaxel-coated-devices-treat-peripheral-arterial-disease-unlikely-increase-risk-mortality

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FDA Roundup: July 7, 2023

Murilo Freitas - 20:30, 6 de julio de 2023428

FDA Roundup: July 7, 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-july-7-2023

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Cipla Issues Voluntary Nationwide Recall of Six Batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Due to Container Defect

Murilo Freitas - 04:00, 6 de julio de 2023344

Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as «Cipla»), today announced that its wholly-owned subsidiary Cipla US is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer leve

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/cipla-issues-voluntary-nationwide-recall-six-batches-albuterol-sulfate-inhalation-aerosol-90-mcg-200