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Class I Medical Device Recall: Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy
Recall Class: Class I Date Recall Initiated: October 21, 2011 Product: Salter Labs 7600 Bubble Humidifier, 350cc volume with 6PSI safety valve. Affected humidifiers were distributed from September 21, 2011 to October 17, 2011. Model numbers: 7600-0-50, E7600-0-50, NP7600-0-50 and special order patient kits that contain 7600 bubble humidifiers. Lot numbers: 091911 and 092611. Special…
Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (March 23, 2012)
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be…
RegenArouse: Recall
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Hand-held Dental X-Ray Units: FDA Safety Communication
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Wholistic Herbs, Inc. "Koff and Kold" and "Kold Sore" Spray: Recall – Non
[Posted 02/10/2012] AUDIENCE: Consumer ISSUE: Wholistic Herbs Inc. notified the public it is recalling all quantities of “Koff Kold” spray with herbal extract and “Kold Sore” spray with liquid sea mineral. “Koff Kold” spray with herbal extract is intended to be sprayed into the nose and throat for treatment of colds, flu, cough, stuffy nose,…
FDA Safety Communication: Illegal Sale of Potentially Unsafe Hand-held Dental X-Ray Units
Date Issued: Feb. 10, 2012 Audience: Health care providers including dentists, dental care professionals and veterinarians who have purchased or are considering purchasing a hand-held dental X-ray unit. Device: A small, hand-held device intended for dental X-ray examinations. Purpose: The FDA is issuing this communication to alert health care providers, including dentists, dental care professionals…
Evaluation of Automatic Class III Designation (De Novo) Decision : K112394 added
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Comunicado de la FDA sobre la seguridad de los medicamentos: Nuevo factor de riesgo para la leucoencefalopatÃa multifocal progresiva (PML por sus siglas en inglés) relacionado con Tysabri (natalizumab)
Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de datos Anuncio de seguridad El 20 de enero del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público que ha identificado como factor de riesgo para la leucoencefalopatÃa multifocal progresiva (PML por…
Transcripts of January 11, 2012 Gastroenterology-Urology Devices Panel Meeting
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