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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF, Entrant HF, Gallant HF, Neutrino NxT HF

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avanta, Neutrino NXT, Gallant, Entrant VR ICD and Avant, Neutrino, Gallant and Entrant DR ICD

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

FDA Pre-Market Approval

FDA Class 3 ·Avant HF, Neutrino NxT HF, Gallant HF and Entrant HF CRT-D

ZOLL PAD WITH CPR AID

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 HYBRID SYSTEM

ONESTEP CPR II MULTI-FUNCTION ELECTRODE

FDA 510(k)

FDA Class 3 ·Cardiovascular

OneStep Pediatric CPR Multi-Function Electrode

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA

FDA 510(k)

FDA Class 3 ·Orthopedic

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA Pre-Market Approval

FDA Class 3 ·RESQCPR SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ACTROS+ FAMILY OF PULSE GENERATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMNOS & DROMOS SL PULSE GENERATORS

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval

FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES

ZOLL E SERIES WITH REAL CPR HELP

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL M SERIES WITH REAL CPR HELP

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL E SERIES WITH SEE-THRU CPR

FDA 510(k)

FDA Class 3 ·Cardiovascular

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S (GROWTH-FACTOR ENHANCED MATRIX

ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO

FDA 510(k)

FDA Class 3 ·Cardiovascular

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System