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

FDA Pre-Market Approval

FDA Class 3 ·CRT-P RESYNCHRONIZATION DEVICES: INVIVE, INTUA, VISIONIST, VALITUDE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT RELEASE 4.1.1

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CRT-D RESYNCHRONIZATION DEVICES, COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER DEVICES. ADVANTION, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA AND ALTRUA 2 SUPPORTED

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE™ NXT Release 7.3

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT Release 7.1.5

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE NXT Release 5.0

UniCel DxH 690T Coulter Cellular Analysis System

FDA UDI

Beckman Coulter, Inc.·15099590729110·UniCel DxH 690T Coulter Cellular Analysis System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA AND ALTRUA 2 PACEMAKER's

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT CRT-D's Resynchroniza

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

FDA Pre-Market Approval

FDA Class 3 ·INVIVE, INTUA, VISIONIST, VALITUDE CRT-P's Resynchronization Devoces

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM SUBCUTANEOUS ICD's

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA ICD's

UniCel® DxH 800 Coulter® Cellular Analysis System

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

UniCel® DxH 900 Coulter® Cellular Analysis System

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

UniCel® DxH 800 Coulter® Cellular Analysis System

Device

EU IVDD · Eu Ivd General ·Beckman Coulter Inc.·On the market·32 countries

TEMPLATE AND COUNTER-FIT

FDA 510(k)

FDA Class 2 ·Dental

MyoWorx TM20

FDA 510(k)

FDA Class 2 ·Physical Medicine

POLY SILOXANE IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

POLY SILOXANE IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Dental