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Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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FDA Approves First Medication for Obstructive Sleep Apnea
FDA Approves First Medication for Obstructive Sleep Apnea
http://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea
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FDA Roundup: December 20, 2024
FDA Roundup: December 20, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-20-2024
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FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities
FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities
http://www.fda.gov/news-events/press-announcements/fda-approves-first-acellular-tissue-engineered-vessel-treat-vascular-trauma-extremities
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Early Alert: Nephroscope Sheath Issue from Trokamed GmbH
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors
Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling all lots within expiry of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) 30 mL vials, to the consumer level. This product, which pre-d
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FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers
FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers
http://www.fda.gov/news-events/press-announcements/fda-updates-healthy-claim-providing-refreshed-tool-consumers
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FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease
FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease
http://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host
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Update: Do Not Use BioZorb Marker Implantable Radiographic Marker Devices: FDA Safety Communication
The FDA’s updated information about BioZorb Marker.
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Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated Number of Reports of Atrio-Esophageal Fistula
POLARx Cryoablation Balloon Catheters treat atrial fibrillation. After reports of atrio-esophageal fistula, the use instructions are being updated.
