BEUDAMED
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    Filters Classification: Class I × Regulation: Us FDA × Clear all

    Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

    FDA Enforcement
    Class I ·Terminated·B. Braun Medical, Inc.·July 25, 2012

    UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s guidance, Guidance for Industry and FDA Staff, Replacement Reagent and Instrument Family Policy . DxH 800 intended use states: The UniCel DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel¿ DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) o TNC and RBC

    FDA Enforcement
    Class I ·Terminated·Beckman Coulter Inc.·May 29, 2019

    Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.

    FDA Enforcement
    Class I ·Terminated·Atossa Genetics, Inc.·November 6, 2013

    Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability.

    FDA Enforcement
    Class I ·Terminated·Del Mar Reynolds Medical, Ltd.·March 27, 2013

    ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60

    FDA Enforcement
    Class I ·Completed·Empowered Diagnostics LLC·February 9, 2022

    CovClear COVID-19 Rapid Antigen Test, ATG 900-031

    FDA Enforcement
    Class I ·Completed·Empowered Diagnostics LLC·February 9, 2022

    Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700

    FDA Enforcement
    Class I ·Terminated·Stryker Instruments Div. of Stryker Corporation·August 22, 2012

    Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

    FDA Enforcement
    Class I ·Terminated·Stryker Instruments Div. of Stryker Corporation·August 22, 2012

    Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.

    FDA Enforcement
    Class I ·Terminated·Stryker Instruments Div. of Stryker Corporation·August 22, 2012

    McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction

    FDA Enforcement
    Class I ·Ongoing·Allergan PLC·September 18, 2019

    Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

    FDA Enforcement
    Class I ·Ongoing·DEWEI MEDICAL EQUIPMENT CO LTD·December 14, 2022

    Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit

    FDA Enforcement
    Class I ·Terminated·Lusys Laboratories, Inc.·April 15, 2015

    Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit

    FDA Enforcement
    Class I ·Terminated·Lusys Laboratories, Inc.·April 15, 2015

    Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit

    FDA Enforcement
    Class I ·Terminated·Lusys Laboratories, Inc.·April 15, 2015

    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

    FDA Enforcement
    Class I ·Ongoing·SML Distribution, LLC·May 11, 2022

    Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction

    FDA Enforcement
    Class I ·Ongoing·Allergan PLC·September 18, 2019

    CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep

    FDA Enforcement
    Class I ·Terminated·Custom Medical Specialties, Inc.·September 26, 2012

    CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep

    FDA Enforcement
    Class I ·Terminated·Custom Medical Specialties, Inc.·September 26, 2012

    CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep

    FDA Enforcement
    Class I ·Terminated·Custom Medical Specialties, Inc.·September 26, 2012

    CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep

    FDA Enforcement
    Class I ·Terminated·Custom Medical Specialties, Inc.·September 26, 2012