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    Densitas Inc

    Manufacturer
    🇨🇦 Canada·2 Basic UDI-DIs·5 Devices

    Densitas Inc.

    FDA registration
    Densitas Inc.·2 products·🇨🇦 Canada

    intelliMammo™ densityAI™

    Device
    EU MDR · Eu Md Class 1 ·Densitas Inc·No longer on the market

    densitas® densityAI™

    Device
    EU MDR · Eu Md Class 1 ·Densitas Inc·No longer on the market

    intelliMammo® densityAI™

    Device
    EU MDR · Eu Md Class 1 ·Densitas Inc·No longer on the market

    intelliMammo® densityAI™

    Device
    EU MDR · Eu Md Class 1 ·Densitas Inc·On the market

    MAMMOGRAPHY SYSTEMS - SOFTWARE ACCESSORIES

    Device
    EU MDR · Eu Md Class 1 ·Densitas Inc·No longer on the market

    intelliMammo® densityAI™

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Densitas Inc·1 device

    intelliMammo™ densityAI™

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Densitas Inc·4 devices

    AF Pharma Service Europe SL

    Authorized representative
    🇪🇸 Spain·51 Manufacturers·881 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    SEVEN XD INT. HEX. IMPLANT D3.75 L10MM SP

    FDA Adverse Event
    Injury ·MIS IMPLANTS TECHNOLOGIES LTD.·Product code DZE·April 1, 2026

    ClearChem Diagnostics Inc. High-Density Lipoprotein (HDL) Cholesterol

    FDA UDI
    CLEARCHEM DIAGNOSTICS INC.·00852169008164·In Vitro Diagnostics testing kit R1:3X45mL, R2:...

    ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol

    FDA UDI
    CLEARCHEM DIAGNOSTICS INC.·00852169008201·In Vitro Diagnostics testing kit R1:3X45mL, R2:...

    NATRELLE SILICONE-FILLED BREAST IMPLANTS

    FDA Adverse Event
    Injury ·ALLERGAN·Product code FTR·April 2, 2014

    MONACO

    FDA Adverse Event
    Malfunction ·ELEKTA INC.·Product code MUJ·July 3, 2020

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·January 11, 2024

    CM DRIVE ACQUA IMPL TI 3.5X13

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·January 8, 2018

    CM DRIVE ACQUA IMPL TI 4.3X11.5

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·January 8, 2018

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code MTD·March 14, 2024