by Shelley Wood Shelley Wood is the Editor-in-Chief of TCTMD and the Editorial Director at CRF. She did her undergraduate degree at McGill… Read Full Bio Sources Disclosures Comments US Food and Drug Administration. Edwards Lifesciences recalls the IntraClude intra-aortic occlusion device due ...
US Food and Drug Administration. Medtronic recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-Ds) due to risk of shortened battery life. Published and Accessed on: April 12, 2021....
ingentaconnectGray Sheet
biomedical safety & standards
10.FDA's Recalls (FDA的召回) accessdata.fda.gov/scri 11.483和警告信 fda.gov/AboutFDA/Center 12.Class I / II Exemption ( FDA 豁免的I类和II类设备) fda.gov/MedicalDevices/ 13.Medical Device Exemptions (510(k) 豁免目录 ) accessdata.fda.gov/scri 14.FDA MDSAP fda.gov/medical-devices...
The Food and Drug Administration (FDA) on March 6 identified the recall by Becton Dickinson (BD)/CareFusion 303 of its Alaris System Infusion Pumps and Modules as Class I, the most serious. The recall was initiated because of multiple system errors, software errors, and use-related errors. ...
Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use. "When deciding whether a recall warrants device removal from the field, the FDA considers the freq...
FDA制裁的方式:罚没Seizure、扣留Detention、限制命令和禁令Restraining Orders and Injunctions、召回Recalls、罚款Penalties 如何应对FDA510(K)产品的设计变更 产品设计变更依据的法规:在获得FDA510(K)后,如果您对产品进行了设计变更,您需要按照FDA法规要求进行确认,以判断是否需要递交新的FDA510(K),或直接进行备案。通常...
FDA官网网址：http://www.fda.gov FDA官网查询网址https://www.accessdata.fda.gov/scripts/cdrh/cf...
The Food and Drug Administration (FDA) deemed a recall of theAsensus SurgicalSenhance surgical robot as Class I, the most serious kind. Asensus recalled its Senhance system due to malfunctions causing unintended movement of the robotically-assisted surgical device. ...