Fluorescence Imaging For Breast Cancer Detection

FDA Pre-Market Approval

FDA Class 3 ·Lumicell Direct Visualization System

Fluorescence Imaging For Breast Cancer Detection

FDA Pre-Market Approval

FDA Class 3 ·Lumicell Direct Visualization System (DVS)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CATH NAVISTAR & RMT THERMOCOOL CATHS,THERMOCOOL SF, SMARTTOUCH& NAV CATH

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

FDA Pre-Market Approval

FDA Class 3 ·Electrophysiology Cable; SE-Safire TX, Catheter Extension Cable; Therapy 8mm, Thermistor, Dual 8, Safire TX Ablation Cat

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CLARITY /VITATRON DA+ C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+ T-SERIES/TOPAZ 3/VITA 2/VITA IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CLARITY/VITATRON DA+C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+T-SERIES/TOPAZ 3/VITA 2/VITA IPGS

Skintact, various other tradenames

FDA 510(k)

FDA Class 3 ·Cardiovascular

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-PMMA PCL'S

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve System; CoreValve Evolut R System; CoreValve Evolut PRO System

Aspiration Therapy System

FDA classification

FDA Class 3 ·Aspiration Therapy System

LIFEPAK 12 BIPHASIC

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY

FDA 510(k)

FDA Class 3 ·Cardiovascular

INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

PELLETHANE 75D

FDA 510(k)

FDA Class 3 ·Cardiovascular

STELA MODEL UJ45 PACING LEADS

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL M SERIES ETCO2 OPTION

FDA 510(k)

FDA Class 3 ·Cardiovascular

PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)

FDA 510(k)

FDA Class 3 ·Cardiovascular

AECD ARRHYTHMIA DETECTION SOFTWARE

FDA 510(k)

FDA Class 3 ·Cardiovascular