NuBorne Infant Warmer

FDA 510(k)

FDA Class 2 ·General Hospital

BIOFUSIONARY BEBE

FDA 510(k)

FDA Class 2 ·Physical Medicine

PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo

FDA 510(k)

FDA Class 2 ·Ophthalmic

GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS

FDA 510(k)

FDA Class 2 ·Anesthesiology

OPTIGEN ALLERGEN SPECIFIC IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

AeroNOx 2.0 Nitric Oxide Titration & Monitoring System

FDA 510(k)

FDA Class 2 ·Anesthesiology

WALLSTENT ESOPHAGEAL PROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL

FDA 510(k)

FDA Class 2 ·Orthopedic

SYSTEM 100 ULTRAFILTRATION CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKYLARK GB 1000

FDA 510(k)

FDA Class 2 ·Neurology

CODMAN ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601

FDA 510(k)

FDA Class 2 ·Orthopedic

INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TI-FRAME

FDA 510(k)

FDA Class 2 ·Orthopedic

CapSure® PS System

FDA 510(k)

FDA Class 2 ·Orthopedic