Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)

FDA 510(k)

FDA Class 2 ·General Hospital

Onycho Laser V

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Clean Connecting Tube

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

UCENTUM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO: NUVASIVE SPHERX II SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES

FDA 510(k)

FDA Class 2 ·Orthopedic

SAFE-1 VENOUS RESERVOIR

FDA 510(k)

FDA Class 2 ·Cardiovascular

rainbow LS Block

FDA 510(k)

FDA Class 2 ·Dental

Sphincterotome

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TEMPERATURE DIAGNOSTIC ACCESSORY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

A/C ENZYMATIC VITAMIN B6 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO: NUVASIVE SPHERX SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLYSTAN HEART-LUNG MACHINE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TEZO TITANIUM CAGE FAMILY

FDA 510(k)

FDA Class 2 ·Orthopedic

MRI Patient Monitor TeslaDUO

FDA 510(k)

FDA Class 2 ·Cardiovascular

DV-300 Aspirator

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Surgical Gown (Sterile), Surgical Gown (Non-sterile)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular