BEUDAMED
    5,284 results · 41ms · Sources: EU EUDAMED, US FDA

    Splint, Nasal

    FDA classification
    FDA Class 1 ·Splint, Nasal

    Babesia Spp. Serological Reagents

    FDA classification
    FDA Not Classified ·Babesia Spp. Serological Reagents

    Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

    FDA classification
    FDA Class 2 ·Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens

    Bartonella Spp. Serological Reagents

    FDA classification
    FDA Not Classified ·Bartonella Spp. Serological Reagents

    Orientia Spp. (Scrub Typhus) Serological Reagents

    FDA classification
    FDA Not Classified ·Orientia Spp. (Scrub Typhus) Serological Reagents

    Implanted Fecal Incontinence Device

    FDA Pre-Market Approval
    FDA Class 3 ·AMS ACTICON NEOSPHINCTER-ARTIFICIAL BOWL SPHINCTER (ABS)

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS)

    Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

    FDA classification
    FDA Not Classified ·Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

    160841CE01

    Certificate
    MDD Annex II (excluding section 4)·NP Medical, Inc.·DEKRA Certification B.V.·1 Basic UDI-DI

    pfm medical cpp

    System producer
    🇨🇭 Switzerland

    Yersinia Spp. Reagents

    FDA classification
    FDA Unclassified ·Yersinia Spp. Reagents

    Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

    FDA classification
    FDA Class 2 ·Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody

    Active Anthrax DetectTM Plus Rapid Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    The SensiTox B. anthracis Toxin Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Stichting Apps for Care and Science

    Authorized representative
    🇳🇱 Netherlands

    Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

    FDA classification
    FDA Class 2 ·Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

    Cryptosporidium Spp.

    FDA classification
    FDA Class 2 ·Cryptosporidium Spp.

    Giardia Spp.

    FDA classification
    FDA Class 2 ·Giardia Spp.

    Campylobacter Spp.

    FDA classification
    FDA Class 1 ·Campylobacter Spp.