Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·CODMAN MODEL 3000 SERIES CONSTANT FLOW IMPLANTABLE PUMP

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·FLEXTIP PLUS INTRASPINAL CATHETER KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE FAMILY OF LEADS

CODMAN ISOCOOL BIPOLAR FORCEPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENVOY GUIDING CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

CODMAN FLEXIBLE ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CODMAN SOF'WIRE TITANIUM CABLE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

YASARGIL SUCTION TUBE - MEDIUM

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

CHEEK TOOL SET

FDA 510(k)

FDA Class 2 ·Neurology

OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT

FDA 510(k)

FDA Class 2 ·Orthopedic

MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER

FDA 510(k)

FDA Class 2 ·Neurology

ACCU-FLO PRESSURE VALVE

FDA 510(k)

FDA Class 2 ·Neurology

DENVER PERITONEO-VENOUS SHUNT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DENVER PERITONEO-VENUS SHUNT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223

FDA 510(k)

FDA Class 2 ·Neurology

VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM

FDA 510(k)

FDA Class 2 ·Neurology

CODMAN BACTISEAL EVD CATHETER SET

FDA 510(k)

FDA Class 2 ·Neurology

ENVOY GUIDING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular