Momentum® MIS Posterior Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Auto Positioning

FDA 510(k)

FDA Class 2 ·Radiology

GUARDIAN-SG Inflatable Bone Expander System

FDA 510(k)

FDA Class 2 ·Orthopedic

PROPENCIL ESU PENCIL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Procedural Ear-loop Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPACELABS MODEL 90419 PULSE OXIMETER MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8

FDA 510(k)

FDA Class 2 ·General Hospital

Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CHARTIS CATHETER MODEL CHR-CA-12.0

FDA 510(k)

FDA Class 2 ·Anesthesiology

Stone Retrieval Balloon

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPACELABS ARRHYTHMIA NET (TM) LEVEL 2

FDA 510(k)

FDA Class 2 ·Cardiovascular

uCerv Flux-C 3D Porous Titanium Cervical Interbody

FDA 510(k)

FDA Class 2 ·Orthopedic

Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1

FDA 510(k)

FDA Class 2 ·Cardiovascular

Disposable Hemoclip

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NUVASIVE SPHERX II SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GOLDEN GATE ANTERIOR PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FREND PSA PLUS (reagent cartridge)

FDA 510(k)

FDA Class 2 ·Immunology

Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology