450 results · 25ms · Sources: EU EUDAMED, US FDA

Simplexa COVID-19 Direct

FDA 510(k)
FDA Class 2 ·Microbiology

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)
FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)
FDA Class 2 ·Hematology

INVADER MTHFR 1298

FDA 510(k)
FDA Class 2 ·Hematology

INVADER MTHFR 677

FDA 510(k)
FDA Class 2 ·Hematology

MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Bcr/Abl1 Monitoring Test

FDA classification
FDA Class 2 ·Bcr/Abl1 Monitoring Test

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)
FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)
FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)
FDA Class 2 ·Microbiology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)
FDA Class 2 ·Microbiology

NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

FDA 510(k)
FDA Class 2 ·Microbiology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval
FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

GYMFORM DUAL FLEX BELT MODEL WB-162

FDA 510(k)
FDA Class 2 ·Physical Medicine

PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN

FDA 510(k)
FDA Class 2 ·General Hospital

DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE

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

RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE

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

PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS

FDA 510(k)
FDA Class 2 ·General Hospital

SURGICAL SUTURE, NONABSORABLE STAINLESS STEEL

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

PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI

FDA 510(k)
FDA Class 2 ·General Hospital