Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Plexa ProMRI DF-1 S DX 65/17, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI S 60,

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS, WITH THERMAFIX TISSUE PROCESS, RSR PERICARDIAL AORTIC BIO

BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·Barostim NEO Generator, Barostim NEO2 Generator, Barostim Carotid Sinus Lead, Programmer System, Carotid Sinus Lead Repa

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACTROS, AXIOS, CYLOC, DROMOS, ERGOS, GEMNOS, KAIROS, KALOS, NANOS, NEOS, PHILOS, PHILOS II, PIKOS, PROTOS, TRIOS, BA03..

DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325

FDA 510(k)

FDA Class 3 ·Cardiovascular

ONESTEP CPR II MULTI-FUNCTION ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003

FDA 510(k)

FDA Class 3 ·Cardiovascular

PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005

FDA 510(k)

FDA Class 3 ·Cardiovascular

OneStep Pediatric CPR Multi-Function Electrode

FDA 510(k)

FDA Class 3 ·Cardiovascular

CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES

FDA 510(k)

FDA Class 3 ·Cardiovascular

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 IQFISH PHARMDX

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMDX KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·HERCEP TEST

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·DAKOCYTOMATION HER2 FISH PHARMDX KIT

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·HER2 FISH PHARMADX KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·DAKOCYTOMATION HERCEP TEST

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·DAKOCYTOMATION HER2 FISH PHARMDX KIT