BEUDAMED
    3,559 results · 66ms · Sources: EU EUDAMED, US FDA

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·RESOLUTION ctDx FIRST

    Forceps, Biopsy, Non-Electric, Reprocessed

    FDA classification
    FDA Class 1 ·Forceps, Biopsy, Non-Electric, Reprocessed

    Shoulder Prosthesis, Reverse Configuration

    FDA classification
    FDA Class 2 ·Shoulder Prosthesis, Reverse Configuration

    Pediatric/Child Facemask

    FDA classification
    FDA Class 2 ·Pediatric/Child Facemask

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx (F1 Liquid CDx)

    Sharkmed Oy

    Importer
    🇫🇮 Finland·18 Manufacturers

    Bed-Patient Activity Monitoring System

    FDA classification
    FDA Class 1 ·Bed-Patient Activity Monitoring System

    Mini Endoscope, Gastroenterology-Urology

    FDA classification
    FDA Class 2 ·Mini Endoscope, Gastroenterology-Urology

    Medical Technology Promedt Consulting GmbH

    Authorized representative
    🇩🇪 Germany·194 Manufacturers·10009 Devices

    Endoilluminator, Reprocessed

    FDA classification
    FDA Class 2 ·Endoilluminator, Reprocessed

    Kit, Test, Olfactory

    FDA classification
    FDA Class 2 ·Kit, Test, Olfactory

    Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

    FDA classification
    FDA Class 2 ·Software, Similarity Score Algorithm, Tissue Of Origin For Malignant Tumor Types

    Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    FDA classification
    FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

    Washer, Cleaner, Automated, Endoscope

    FDA classification
    FDA Class 2 ·Washer, Cleaner, Automated, Endoscope

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx

    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

    FDA classification
    FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

    mdi Europa GmbH

    Authorized representative
    🇩🇪 Germany·132 Manufacturers·4741 Devices

    Single-Use Reprocessed Ultrasonic Surgical Instruments

    FDA classification
    FDA Unclassified ·Single-Use Reprocessed Ultrasonic Surgical Instruments

    Ovarian Adnexal Mass Assessment Score Test System

    FDA classification
    FDA Class 2 ·Ovarian Adnexal Mass Assessment Score Test System

    Stryker EMEA Supply Chain Services BV

    Importer
    🇳🇱 Netherlands·48 Manufacturers