POOL NORM

FDA 510(k)

FDA Class 2 ·Hematology

Optimas MAX System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MallyaD injection pen adapter (MallyaD)

FDA 510(k)

FDA Class 2 ·General Hospital

All’InCath 035M PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40

FDA 510(k)

FDA Class 2 ·Radiology

IP-SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

EOS System

FDA 510(k)

FDA Class 2 ·Radiology

D²RS and D²RS 9090

FDA 510(k)

FDA Class 2 ·Radiology

MCB UNIT Model: V10GMCBUS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MENIX®; MENIX® DUO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPORT-ELEC, MODELS DUO CT5 SLIMNESS AND CT5 SLIMNESS

FDA 510(k)

FDA Class 2 ·Physical Medicine

Activ Fuse

FDA 510(k)

FDA Class 2 ·Orthopedic

Cyware 4H and Cysart 4H

FDA 510(k)

FDA Class 2 ·Radiology

Nutricair Enteral Syringe with ENFit

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115

FDA 510(k)

FDA Class 2 ·Orthopedic

QUANTUM® Patient Specific Instrumentation (PSI) System

FDA 510(k)

FDA Class 2 ·Orthopedic

VISTA PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

KODAK 9000, KODAK 9000 3D

FDA 510(k)

FDA Class 2 ·Dental