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Há 3 dias · The MAUDE database was accessed on August 22,2022 from the following website: MAUDE - Manufacturer and User Facility Device Experience (fda.gov) and queried for all MDRs containing “WavelinQ” that had been reported to the database up to August 22,2022.
8 de mai. de 2024 · The U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet...
Há 2 dias · Post-marketing surveillance data for the esophageal SEMSs were analyzed using the FDA's MAUDE database from January 2014 to December 10, 2023. The outcomes of interest were patient-related adverse events and device failures. Statistical analysis was performed using Microsoft Excel 2010 and SPSS.
14 de mai. de 2024 · The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the ...
3 de mai. de 2024 · MDR Report Key: 18846210: MDR Text Key: 337154087: Report Number: MW5152338: Device Sequence Number: 1: Product Code: NEU Combination Product (y/n) N: Reporter Country Code
16 de mai. de 2024 · Regulatory Resources. Manufacturer and User Facility Device Experience (MAUDE) FDA database on adverse events (death, serious injury or malfunction) involving medical devices, starting in 1993. Device Advice: Comprehensive Regulatory Assistance (FDA) Text-based resource that explains many aspects of medical device laws, regulations ...
20 de mai. de 2024 · Siemens Healthineers recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for four computed tomography (CT) scanners. These include the SOMATOM Edge Plus, the most recent version of the SOMATOM Force, the SOMATOM go.All and the SOMATOM go.Top.
