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Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
    The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health...

Spire Biomedical, Inc. - International Consortium of …

    https://medicaldevices.icij.org/manufacturers/u-s-food-and-drug-administration-spire-biomedical-inc-spire-biomedical-inc-one-patriots-park-bedford-ma-01730-2343
    Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. About the database How to use …

2022 Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls
    Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices. 10/18/22. Jiangsu Well Biotech …

Medical Device Recalls

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=101&event_id=&productdescriptiontxt=rni¢erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=11%2F21%2F2014&productshortreasontxt=&firmlegalnam=&knumber=&pnumber=&sortcolumn=
    Spire Biomedical, Inc. 36CM ALTA LR STANDARD KIT Model: AL31NH36 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyurethane t... 2 11/17/2009 Spire …

Medical Device Recalls

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=11&event_id=&productdescriptiontxt=pee&productcode=&rootCauseText=¢erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=11%2F12%2F2014&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=pda
    Spire Biomedical, Inc. 28CM ALTA LR STANDARD KIT Model: AL23NH28 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyurethane... 2 11/17/2009 Spire …

Class 2 Device Recall Decathlon Gold - accessdata.fda.gov

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=85993
    Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire …

Medical Device Recalls

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=301&event_id=&productdescriptiontxt=dil&productcode=&rootCauseText=¢erclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&sortcolumn=cda
    Spire Biomedical, Inc. 28CM ALTA LR STANDARD KIT High Flow Recirculation Model: AL23SH28 ALTA CATHETER WITH SIDE HOLES... 2 11/17/2009 Spire Biomedical, Inc. …

Class 2 Device Recall Decathlon - accessdata.fda.gov

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85973
    Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical …

Class 2 Device Recall Decathlon - Food and Drug …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=85974
    Spire Medical issued an "Urgent device Recall" letter dated 10/22/09 by FEDEX to end users. Users are requested to return product. For questions, contact Spire Biomedical …

International Medical Devices Database

    https://medicaldevices.icij.org/events/usa-alta-f7f974e7-e783-428d-af9c-867eb20dff2e
    According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spire Biomedical, Inc.. What is this? A correction or …



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