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

AirLife

FDA UDI

Carefusion Corporation·10885403184857·Airlife™ LVN Kit, Face Tent Mask with 6' ...

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC COREVALVE SYSTEM

Crimper, Wire, Ent, Non-Sterile

FDA classification

FDA Class 1 ·Crimper, Wire, Ent, Non-Sterile

Woodpecker rasping machine surgical add-on tool

Basic UDI-DI

EU MDR · Eu Md Class 1 ·IMT Integral Medizintechnik AG·1 device

STERICELL

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMT Medical Technology s.r.o.·1 device

UNISTERI HP; UNISTERI SL

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMT Medical Technology s.r.o.·2 devices

STERIVAP SL

Basic UDI-DI

EU MDR · Eu Md Class 2a ·BMT Medical Technology s.r.o.·1 device