AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

Illusion Aligner Pro: Illusion Aligner FLX

FDA 510(k)

FDA Class 2 ·Dental

CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid

FDA 510(k)

FDA Class 2 ·Dental

Pitkar Spinal Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

MAF Guard

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Polyfusion IV Administration Sets

FDA 510(k)

FDA Class 2 ·General Hospital

DigiX FDX

FDA 510(k)

FDA Class 2 ·Radiology

GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive

FDA 510(k)

FDA Class 2 ·Orthopedic

EzVu Visual Vasopressor injector (EV-19)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

CPRmeter 2 CPR Feedback Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

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