Medsynapse Ris Pacs & Medsynapse VNA

FDA 510(k)

FDA Class 2 ·Radiology

UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD SPECTRIS MR INJECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDRAD QWIK-FIX MRI DISPOSABLE KIT

FDA 510(k)

FDA Class 2 ·Radiology

Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE

FDA 510(k)

FDA Class 2 ·Orthopedic

WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

PRORAD X-Ray Flat Panel Detector with DROC

FDA 510(k)

FDA Class 2 ·Radiology

Central Venous Catheter Tray

FDA classification

FDA Class 2 ·Central Venous Catheter Tray

Endoscopic Pancreatic Debridement Device

FDA classification

FDA Class 2 ·Endoscopic Pancreatic Debridement Device

Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System

FDA 510(k)

FDA Class 2 ·Orthopedic

System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

FDA classification

FDA Class 2 ·System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

HEMODIALYSIS TUBING SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)

LYMA Laser

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Beddr 200 System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LYMA Laser PRO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE

FDA 510(k)

FDA Class 2 ·Cardiovascular