EZTEST-STEAM

FDA 510(k)

FDA Class 2 ·General Hospital

PROLITE III TOWER AND PR AND HR HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

X-spine Cortical Bone Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Cortera™ Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

ALLOX2 TISSUE EXPANDERS

FDA 510(k)

FDA Unclassified ·Unknown

SMART-READ EZTEST-STEAM SCBI AND TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

ACCOMMODATOR WHEELCHAIR, MODEL #2000X

FDA 510(k)

FDA Class 1 ·Physical Medicine

MODIFICATION TO FLUROTEX SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MAMMARY SIZER

FDA 510(k)

FDA Unclassified ·Unknown

VIRILIS PENILE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SILICONE ELASTOMER SHEETING

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PROLITE PULSED LIGHT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO FLUOROTEX II SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intimate Rose Rectal Dilator - Size 8

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Plus EV Holdings·1 device

Genvinset® MTHFR multiplex

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Blackhills Diagnostic Resources S.L.U.·3 devices

Galena Saglik San ve Tic A.S.

Importer

🇹🇷 Türkiye·1 Manufacturer

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF RESTOR INTRAOCULAR LENS

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses