System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·BOND ORACLE HER2 IHC SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·DAKO HERCEPTEST

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·Bond Oracle HER2 IHC System

SONO 5

FDA 510(k)

FDA Class 2 ·Physical Medicine

GALVA-5-M

FDA 510(k)

FDA Class 2 ·Physical Medicine

WAVELIGHT IDAS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GALVA 5-T

FDA 510(k)

FDA Class 2 ·Neurology

TrapIt

FDA 510(k)

FDA Class 2 ·Cardiovascular

Guidion

FDA 510(k)

FDA Class 2 ·Cardiovascular

ReCross

FDA 510(k)

FDA Class 2 ·Cardiovascular

NHANCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CEP XY, HER2/neu, UroVysion, ALK

Basic UDI-DI

EU IVDD · Eu Ivd General ·Applied Spectral Imaging Ltd·1 device

Dental stone

Basic UDI-DI

EU MDR · Eu Md Class 1 ·JINGMEN TZU SHE TANG GYPSUM CO., LTD·1 device

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL Absorbable Hemostats

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Zilver PTX Drug-Eluting Peripheral Stent

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System