CONTOUR TECHNOLOGY MUSCLE STIMULATOR

FDA 510(k)

FDA Class 2 ·Physical Medicine

I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ENDLESSFIBER REUSABLE SURGICAL LASER FIBER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

iSLEEVE Introducer Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRO-INDUCTION 1000 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERILEMED REPROCESSED IVUS IMAGING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)

FDA 510(k)

FDA Class 2 ·Cardiovascular

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL

FDA 510(k)

FDA Class 2 ·Neurology

ENSITE 3000 SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

IMPEDANCE/8200 MONITOR-MODEL 8300

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pounce Thrombectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Diamondback 360 Peripheral Orbital Atherectomy System

FDA 510(k)

FDA Class 2 ·Cardiovascular

1,25-DIHYDROXYVITAMIN D125I RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Shape-HF Cardiopulmonary Testing System

FDA 510(k)

FDA Class 2 ·Anesthesiology

R&D RETIC-PG HEMATOLOGY CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic