PLASMINOGEN RID TEST KIT

FDA 510(k)

FDA Class 1 ·Immunology

HELENA PLASMINOGEN QUIPLATE PROCEDURE

FDA 510(k)

FDA Class 1 ·Immunology

LAS-R HUMAN PLASMINOGEN TEST

FDA 510(k)

FDA Class 1 ·Immunology

LSA 290 ASSAY REAGENTS/NEPHELOMETRIC

FDA 510(k)

FDA Class 1 ·Immunology

ANTI SERA TO HUMAN OROSCOMUCOID

FDA 510(k)

FDA Class 1 ·Immunology

ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU

FDA 510(k)

FDA Class 1 ·Immunology

Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Oral Matrix

FDA 510(k)

FDA Class 2 ·Dental

Disposable Laparoscope Trocar

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Diode Laser Hair Removal System (MBT-Diode Laser)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Medical Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO CONTOUR SE MICROSPHERES

FDA 510(k)

FDA Class 2 ·Neurology

Disposable Specimen Retrieval Bag

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medical Surgical Gowns

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

hybcell Bacteria DNA xB

Device

EU IVDD · Eu Ivd General ·Cube Dx GmbH·On the market·32 countries

hybcell Fungi DNA xB

Device

EU IVDD · Eu Ivd General ·Cube Dx GmbH·On the market·32 countries

hybcell Pathogens DNA xB

Device

EU IVDD · Eu Ivd General ·Cube Dx GmbH·On the market·32 countries

PCR-Box Bacteria

Device

EU IVDD · Eu Ivd General ·Cube Dx GmbH·On the market·32 countries

PCR-Box Fungi

Device

EU IVDD · Eu Ivd General ·Cube Dx GmbH·On the market·32 countries

GINA 500

Device

EU IVDD · Eu Ivd General ·Cube Dx GmbH·On the market·32 countries