EMBRYON ULTRASOUND NEEDLE GUIDE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

The Circadia C200 System

FDA 510(k)

FDA Class 2 ·Cardiovascular

HABIB ENDOHPB

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RANDOX CALCIUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MCGRATH ORTHOPAEDIC BONE SCREWS

FDA 510(k)

FDA Class 2 ·Orthopedic

HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS

FDA 510(k)

FDA Class 2 ·Immunology

CLEARBLUE EASY DIGITAL PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VICKERS MEDICAL MODEL 273 OXYGEN MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20

FDA 510(k)

FDA Class 2 ·Anesthesiology

Magseed Pro Magnetic Marker System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOTRACE-N, NS, 410 AND RT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Neoss Individual Prosthetics

FDA 510(k)

FDA Class 2 ·Dental

PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Brainomix 360 e-CTA

FDA 510(k)

FDA Class 2 ·Radiology

EchoGo Amyloidosis (1.0)

FDA 510(k)

FDA Class 2 ·Cardiovascular

AUTOSTAT II ANTI-SCL-70 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

Digitimer DS7AP Constant Current Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Creo Electrosurgical System with NP1 Instrument

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery