ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

FDA 510(k)

FDA Class 2 ·Immunology

SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRUFREEZE SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES

FDA 510(k)

FDA Class 2 ·General Hospital

FENCER 308 EXCIMER LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ICT

FDA 510(k)

FDA Class 2 ·Radiology

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

FDA 510(k)

FDA Class 2 ·Radiology

HyPHo Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

FDA 510(k)

FDA Class 2 ·Neurology

IMRIS ONCOLOGY PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

ARCHITECT STAT CK-MB IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

ORAJEL ADVANCED TOOTH DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION

FDA 510(k)

FDA Class 2 ·Dental

ARCHITECT STAT TROPONIN-1; MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT STAT MYO IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT STAT TROPONIN-I IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·INTER FIX THREADED FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·VISTA LORDOTIC INTERBODY FUSION CAGE