HAYMAX

FDA 510(k)

FDA Class 2 ·General Hospital

CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

PROTEX, TAHITI CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE

FDA 510(k)

FDA Class 2 ·Neurology

FLEXI-STAT SP02 EAR SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

extriCARE® 3000 Negative Wound Pressure Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SpermAlign Sperm Separation Device

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Air Next

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPO2 WRAP SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

RANEY CLIPS

FDA 510(k)

FDA Class 2 ·Neurology

MODULOCK POSTERIOR SPINAL FIXATION

FDA 510(k)

FDA Class 2 ·Orthopedic

ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)

FDA 510(k)

FDA Class 2 ·Neurology

BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

POINT SETTER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

VACULINK, MODEL VCL 3000

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ADAPT OPEN ACCESS PORT, MODEL 41233

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology