restor3d Reverse Total Shoulder Arthroplasty System

FDA 510(k)

FDA Class 2 ·Orthopedic

COAG-A-MATE - RA4

FDA 510(k)

FDA Class 2 ·Hematology

EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET

FDA 510(k)

FDA Class 2 ·Anesthesiology

PALOMAR SLP 2000

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

T-Line® Hernia Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ECHOTIP(R) ULTRA FIDUCIAL NEEDLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CYCLE BP MONITOR AND PULSE OXIMETER, MODEL 1060

FDA 510(k)

FDA Class 2 ·Cardiovascular

StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle

FDA 510(k)

FDA Class 2 ·Anesthesiology

PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

Senhance Surgical System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VPDS-1 VENNES PANCREATIC DILATION SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Comfort Flo Humidification System

FDA 510(k)

FDA Class 2 ·Anesthesiology

THE WONDER BOX

FDA 510(k)

FDA Class 2 ·Neurology

Acrobat Calibrated Tip Wire Guide

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMX T3 ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Extremity Staple

FDA 510(k)

FDA Class 2 ·Orthopedic