BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BAY SHORE MEDICAL EQUIPMENT, LLC

    Reg #: 3005810333 · FEI: 3005810333 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    74
    Establishment Types
    1
    Classifications
    18

    Registration Details

    Registration Name
    BAY SHORE MEDICAL EQUIPMENT, LLC
    Registration Number
    3005810333
    FEI Number
    3005810333
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    61 Deer Lane
    City
    Manorville
    State
    NY
    ZIP
    11949
    Country
    US

    Regulatory Submissions

    510(k) Number
    K982795
    PMA Number
    P080003

    Owner / Operator

    Firm Name
    Bay Shore Medical Equipment, LLC
    Operator Number
    10037139
    Address
    61 Deer Lane
    City
    Manorville
    State
    NY
    Postal Code
    11949
    Country
    US
    Correspondent
    John Kollegger

    Products

    Device Name Product Code
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB
    System, X-Ray, Stationary KPR
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, X-Ray, Fluoroscopic, Image-Intensified JAA
    Image-Intensified Fluoroscopic X-Ray System, Mobile OXO
    Interventional Fluoroscopic X-Ray System OWB
    System, X-Ray, Tomography, Computed JAK
    System, X-Ray, Mobile IZL
    System, Nuclear Magnetic Resonance Imaging LNH
    System, X-Ray, Angiographic IZI
    System, X-Ray, Mammographic IZH
    System, Nuclear Magnetic Resonance Spectroscopic LNI
    Camera, Multi Format, Radiological LMC
    System, Tomography, Computed, Emission KPS
    Full Field Digital, System, X-Ray, Mammographic MUE
    Digital Breast Tomosynthesis OTE

    Proprietary Names

    Philips Bucky Diagnost CS Philips Bucky Diagnost VE Philips Bucky Diagnost TH Philips Bucky Diagnost VT Logiq P5 Ultrasound GE OEC 9800 Plus C-arm GE OEC 9800 C-arm Siemens Somatom Sensation 16 CT Scanner Siemens Somatom Sensation 64 CT Scanner Siemens Somatom Sensation 40 CT Scanner Siemens Somatom Sensation 64 Cardiac CT Scanner Siemens Mobilette XP Hybrid Siemens Mobilette XP Siemens Mobilette XP Eco Siemens Symphony Fuji XG1 CR Reader Fuji Clearview CSM CR Reader, Fuji Profect CR Reader Philips Allura Xper FD10 Cath Lab Lorad MIV Mammography Unit Philips 1.5T Intera MRI Scanner GE OEC Flexview 8800 C-arm GE Logiq 9 Transduccers (3.5c, 3.5cs, M7C, 8C, E8C, 7L, M8L, 10L, i12L, M12L, 3S, 7S, 10S, 2D, 6D) GE Logiq 9 Ultrasound Siemens Avanto 1.5T 18 Channel MRI Machine FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L GE Brightspeed Elite GE Brightspeed Elite Select BrightSpeed Excel Select BrightSpeed Edge Select Brightspeed 16 Philips Achieva 3T MRI Scanner Kodak CR Reader Kodak 5800 LAser Imager GE AMX III X-Ray, GE AMX IV portable X-Ray Siemens Siremobil Compact L C-arm Philips BV29 C-arm Philips Practix Convenio Siemens Ecat Accel PET Scanner GE Highspeed CT/e Dual CT Scanner GE Prospeed F2 CT Scanner GE Lightspeed 16 CT scanner Siemens Mammomat Inspiration Mammography Machine Siemens Mammomat Inspiration Philips Intera 1.5T MRI Scanner OPTIMA MR450W 1.5T DISCOVERY MR450 1.5T Fuji Clearview CRM CR reader Fuji Clearview CSM CR reader Fuji Profect CS CR reader (japanese name) SIEMENS ECAT ACCEL PET SCANNER Siemens 1.5 Espree MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS Philips Allura Bi-plane Cath Lab OEC 9900 Elite GE Discovery 600 PET CT Discovery 600 PET CT GE LightSpeed QXI CT Scanner GE LightSpeed Plus CT Scanner GE HighSpeed QXI CT Scanner GE LightSpeed QX/I CT Scanner GE Voluson I Ultrasound, GE Voluson E Ultrasound GE Vivid I Ultrasound GE 1.5 SIGNA EXCITE MRI Toshiba Aquillion CT Scanner GE AMX4 Plus Portable X-ray GE AMX4 Portable X-ray SIEMENS SIREMOBILE II C-ARM Selenia Dimensions 3D Philips Pulsera C-arm Toshiba Xario LG Ultrasound, Toshiba Xario XG Ultrasound, Toshiba Xario XA ultrasouns GE Profile V MRI Scanner GE Profile 3 MRI Scanner GE Profile IV MRI Scanner GE Profile 2 MRI scanner GE Profile HD MRI Scanner Toshiba Asteion Super 4 CT Scanner Toshiba Asteion 4 CT Scanner Philips Brilliance 40 CT Scanner GE Lightspeed VCT 64 CT Scanner GE Voluson E6

    Establishment Types

    Repack or Relabel Medical Device