STAR 65

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mozec NC-Rx PTCA Baloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Flush Syringe (Prefilled 0.9% normal saline solution)

FDA 510(k)

FDA Class 2 ·General Hospital

DISPOSABLE SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

Medsynapse Ris Pacs & Medsynapse VNA

FDA 510(k)

FDA Class 2 ·Radiology

PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Humerus & Ulna System

FDA 510(k)

FDA Class 2 ·Orthopedic

CURIEPACS (DICOM PACS SOFTWARE)

FDA 510(k)

FDA Class 2 ·Radiology

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

NET BRAND Osteosynthesis Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Illusion Aligners

FDA 510(k)

FDA Class 2 ·Dental

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva

FDA 510(k)

FDA Class 2 ·General Hospital

Dozee VS

FDA 510(k)

FDA Class 2 ·Anesthesiology

STERILE SALINE SOLUTION

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

qXR-CTR

FDA 510(k)

FDA Class 2 ·Radiology

Alveoair Digital Spirometer

FDA 510(k)

FDA Class 2 ·Anesthesiology