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

LC-04S-A

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Zenith Lab (Jiangsu) Co.,Ltd·1 device

DISPOSITIVO DI MISCELAZIONE E PESATURA DI SACCHE DURANTE IL PRELIEVO DI SANGUE

Basic UDI-DI

EU MDD · Eu Md Class 1 ·VASINI STRUMENTI srl·1 device

DCT DILUENT

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

IP85072 x10: Sterile, Single Use, SET AMT 3

Basic UDI-DI

EU MDD · Eu Md Class 2a ·HASA OPTIX·1 device

IP85071 x10: Sterile, Single Use, SET AMT 2

Basic UDI-DI

EU MDD · Eu Md Class 2a ·HASA OPTIX·1 device

IP85070 x10: Sterile, Single Use, SET AMT 1

Basic UDI-DI

EU MDD · Eu Md Class 2a ·HASA OPTIX·1 device

TWEED Arch Forming Pliers 12 cm T/C

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Nadir & CO·1 device