Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Blazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATOMED SILICONE OIL OP5000

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE 4-SITE DEFIBRILLATION LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIGOR, MERIDIAN, DISCOVER FAMILIES OF PACEMAKER

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·Trident Alumina Insert

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK AV, VENTAK PRIZM, VITALITY, CONFIENT, TELIGEN, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF CRT-DS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AID-B/BR AND VENTAK ICD

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR, INVIVE, INTUA FAMILIES OF CRT-PS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX, VENTAK MINI FAMILIES OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PULSAR, PULSAR MAX, DISCOVER, INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO FAMILIES OF PACEMAKER

LIPASE DETERMINATION

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIPASE TEST KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DELTATEST (R) LIPASE II

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SERUM LIPASE REAGENT SET (TURBIDIMETRIC)

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIPASE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

HARLECO BRAND CLINICARD LIPASE TEST SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

NUCLIPASE (I125) PANCREATIC LIPASE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LIPASE REAGENT SET

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

BECKMAN EPSILON(TM) LIPASE TEST KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry