KLEIN RECTAL TAMPNADE BALLOON

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED

FDA 510(k)

FDA Class 2 ·Orthopedic

TRABECULAR METAL PRIMARY HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation

FDA 510(k)

FDA Class 2 ·Anesthesiology

STRUXXURE® MCS Anterior Cervical Plate System

FDA 510(k)

FDA Class 2 ·Orthopedic

GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET

FDA 510(k)

FDA Class 2 ·Cardiovascular

EDWARDS SACRAL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

G-SCAN CERVICAL SPINE COIL

FDA 510(k)

FDA Class 2 ·Radiology

Biodesign Otologic Repair Graft

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

DEPUY ENDURANCE CALCAR HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACCENT DG BALLOON URETERAL DILATOR SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)

FDA 510(k)

FDA Class 2 ·Anesthesiology

240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS

FDA 510(k)

FDA Class 2 ·Radiology

INDEX ACETABULAT COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1

FDA 510(k)

FDA Class 2 ·Anesthesiology

VERSA-DIAL HUMERAL HEAD PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

ZCH ALPHA SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic