4,514 results · 41ms · Sources: EU EUDAMED, US FDA

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·BD OVD 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·CVX-3000 EXCIMER LASER CORONARY ATHRECTOMY (ELCA) SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·On- X Prosthetic Heart Valve, Ascending Aortic Prothesis

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)

ENDOGATOR™ Hybrid Irrigation Tubing

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AquaPulse Auxiliary Water Connector

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BARD(R) SYRINGE ASSIST IRRIGATION

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ENDIUS SUCTION/IRRIGATION INSTRUMENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ASPIRATION & IRRIGATION CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GATEWAY ADVANAGE Y-ADAPTER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CONTINUOUS FLOW SYSTEM, CFS-1 PUMP SYSTEM (4-700-00)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Endoscopic Water Pump

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

REDSENSE ALARM SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HOBBS MISTIFIER SPRAY CATHETER

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

UNIVERSAL IRRIGATION SOLUTION HYBRID

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BIOPSY VALVE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

C2 CryoBalloon EndoGrip

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

LAVAGING CATHETERS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology