QCU ANALYTICAL SOFTWARE PACKAGE

FDA 510(k)

FDA Class 2 ·Radiology

GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BPCARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENSAIRE DIAGNOSTIC SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPIROCARD

FDA 510(k)

FDA Class 2 ·Anesthesiology

EKGCARD SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

QRS Dental Implants System

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO: BPCARD, MODEL Z-7000-0700

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)

FDA 510(k)

FDA Class 2 ·Dental

SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE® THC Urine Strip Test

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Powered Muscle Stimulator (Model name:MagGraver F200)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ancora Nerve Block Catheter Set

FDA 510(k)

FDA Class 2 ·Anesthesiology