SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

RCHIVE PACS

FDA 510(k)

FDA Class 2 ·Radiology

Pitkar DeftFix System

FDA 510(k)

FDA Class 2 ·Orthopedic

Pitkar External Fixation System - Rail Mechanism

FDA 510(k)

FDA Class 2 ·Orthopedic

Pitkar External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SCANDINAVIAN IVF SCIENCES AB, HYBASE-1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

HOFFMAN IVF-1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Pitkar Spinal Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

MAF Guard

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Magnum

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Phoenix Digital Thermometer

FDA 510(k)

FDA Class 2 ·General Hospital

SCANDINAVIAN IVF SCIENCES AB, G1.2

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Pitkar Locked Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

FORCEPS, SURGICAL, GYNECOLOGICAL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

METIC™- Airway Balloon Catheter

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HIGH SPEED EMG MODULE

FDA 510(k)

FDA Class 2 ·Neurology

OHMEGA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MMS VIDEO OPTION

FDA 510(k)

FDA Class 2 ·Radiology