Idylla™ MSI Test

FDA UDI

Biocartis NV·15415219000758·The Idylla MSI Test, for use on the Idylla Syst...

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx (FICDx)

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (AIOL), MODELS AT-45-HD100, HD500, AND HD520

MSI 2005 SERIES BED

FDA 510(k)

FDA Class 1 ·General Hospital

MSI 2002 SERIES BED

FDA 510(k)

FDA Class 2 ·General Hospital

MSI 9000 SERIES BED

FDA 510(k)

FDA Class 2 ·General Hospital

MSI 3002 SERIES BED

FDA 510(k)

FDA Class 2 ·General Hospital

MSI-HB HEMOGLOBIN CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

MSI 5000 SERIES BED

FDA 510(k)

FDA Class 2 ·General Hospital

MSI 4000 SERIES BED

FDA 510(k)

FDA Class 2 ·General Hospital

GR Resin System MSI

FDA 510(k)

FDA Unclassified ·Unknown

MSI 3003 SERIES BED

FDA 510(k)

FDA Class 1 ·General Hospital

MSI STERNUM ASPIRATION NEEDLE

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MSI-HC HEMATOLOGY CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW

FDA 510(k)

FDA Class 2 ·General Hospital

Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS? MODELS AT-50SE AND AT-52SE ACCOMMODATING INTRAOCULAR LENSES (IOLS)

MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE

FDA 510(k)

FDA Class 1 ·Ophthalmic

OncoMate MSI Dx Analysis System

FDA 510(k)

FDA Class 2 ·Immunology