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Home | SureTek Medical

    https://www.suretekmedical.com/
    Reduced waste. increased device supply. cost savings of >60%. Environmental and Supply Chain sustainability initiatives are a critical link between healthcare providers and their communities. SUD Reprocessing and our paid donor program provide an efficient …

FDA warns SureTek on sterilization, QC issues - MassDevice

    https://www.massdevice.com/fda-warns-suretek-sterilization-qc-issues/
    The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their …

FDA Issues Warning Letter to SureTek Medical Over ... - FDAnews

    https://www.fdanews.com/articles/176638-fda-issues-warning-letter-to-suretek-medical-over-contamination-assessment-issues
    An FDA warning letter takes SureTek Medical to task for its procedures related to assessing contamination for reprocessed single-use devices. The March …

Owler Reports - Suretek Medical: FDA warns SureTek …

    https://www.owler.com/reports/suretek-medical/suretek-medical--fda-warns-suretek-on-sterilizatio/1458153840525
    Suretek Medical: FDA warns SureTek on sterilization, QC issues The FDA issued a warning letter it sent to single use device reprocessor SureTek Medical earlier this …

Warning Letter Roundup & Recap – March 15, 2016 - Medtech …

    https://medtech.pharmaintelligence.informa.com/MT034621/Warning-Letter-Roundup-amp-Recap--March-15-2016
    Specifications developer Innovative Sterilization Technologies cited for quality system and product recall violations; orthopedic and laparoscopic device-maker …

510(k) Premarket Notification - Food and Drug …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K052692
    SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES: Applicant: SURETEK MEDICAL: 44 BELLWOOD FARMS: GREENVILLE, SC 29607 Applicant …

510(k) Premarket Notification - Food and Drug …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K052691
    SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES: Applicant: SURETEK MEDICAL: 44 BELLWOOD FARMS: GREENVILLE, SC 29607 Applicant Contact: MIKE …



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