Pitkar External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

Pitkar Locked Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

FORCEPS, SURGICAL, GYNECOLOGICAL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)

FDA 510(k)

FDA Class 2 ·Radiology

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

SOLAR GI SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO SOLAR GI

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOLAR GI

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOLAR GI

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Artemis Hand Held Imaging System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement

FDA classification

FDA Class 2 ·Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement