103 results · 19ms · Sources: EU EUDAMED, US FDA

AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AURAFLEX TG-AB AND TPO-AB

FDA 510(k)
FDA Class 2 ·Immunology

AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AURAFLEX TPO-AB

FDA 510(k)
FDA Class 2 ·Immunology

AURAFLEX HCG

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IMX T3 ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

3DOSE 1ml Syringe

FDA 510(k)
FDA Class 2 ·General Hospital

CureOs TCP

FDA 510(k)
FDA Class 2 ·Orthopedic

BP 5000

FDA 510(k)
FDA Class 2 ·Cardiovascular

SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Q-Rejuvalight Pro Facewear (Model: P19-0023)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)

FDA 510(k)
FDA Class 2 ·Physical Medicine

Cold Sore Device (Model: QPZ-01)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

LED Lip Perfector, model: ZC-05

FDA 510(k)
FDA Class 2 ·Physical Medicine

Infrared Heat (Model: E0221)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Bioscope Neuromonitor Device

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

LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VERSANT HCV GENOTYPE 2.0 ASSAY (LiPA)

TUF-COAT

FDA 510(k)
FDA Class 2 ·Dental