MCKINLEY OUTBOUND-2 SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

Sonicision Reusable Sterilization Tray

FDA 510(k)

FDA Class 2 ·General Hospital

LANX SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

TANGENT II

FDA 510(k)

FDA Class 2 ·Radiology

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG

FDA 510(k)

FDA Class 2 ·Cardiovascular

OTOMAG BONE CONDUCATION HEARING SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001

FDA 510(k)

FDA Class 2 ·Immunology

MINOLTA SM-32 OXYGEN SATURATION MONIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

PRISMAFLEX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR)

FDA 510(k)

FDA Class 2 ·Dental

HOME-AWAY SYSTEM, MODEL 1041

FDA 510(k)

FDA Class 2 ·Anesthesiology

P-NAIN SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARGON BEAM LAPAROSCOPIC ELECTRODE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Emprint Ablation System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TORQMAX SHEATH GRIP ACCESSORY

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cochlear Osia System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

VERSALAB APM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PHARMASEED, MODEL BT-125-2

FDA 510(k)

FDA Class 2 ·Radiology