HEMO-ALERT

FDA 510(k)

FDA Class 2 ·Cardiovascular

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490C/G/H/J CARELINK REMOTE HOME MONITOR/2020A ANALYZER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC 2490 A/C/D/E/G/H/J CARELINK MONITORS

Absolute Polishers™

FDA UDI

PARKELL, INC.·10810000526014·Absolute Polishers™; Cup Shapers (non-diamond)

Absolute Polishers™

FDA UDI

PARKELL, INC.·10810000526045·Absolute Polishers™; Point Shiners (diamond)

Absolute Polishers™

FDA UDI

PARKELL, INC.·00810000526062·Absolute Polishers™; Assortment (24 pieces)

Enhance® Finishing System/Enhance® PoGo® Polishing System

FDA UDI

DENTSPLY INTERNATIONAL INC.·D0026242051·Enhance Finishing System/Enhance PoGo Polishing...

Enhance® PoGo® Polishing System

FDA UDI

DENTSPLY INTERNATIONAL INC.·D0026620201·Enhance® PoGo® COMPLETE Kit

Absolute Polishers™

FDA UDI

PARKELL, INC.·10810000526021·Absolute Polishers™; Point Smoothers (non-diamond)

Absolute Polishers™

FDA UDI

PARKELL, INC.·10810000526038·Absolute Polishers™; Cup Smoothers (non-diamond)

Absolute Polishers™

FDA UDI

PARKELL, INC.·10810000526007·Absolute Polishers™; Point Shapers (non-diamond)

Absolute Polishers™

FDA UDI

PARKELL, INC.·10810000526052·Absolute Polishers™; Cup Shiners (diamond)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARELINK EXPRESS MONITORS, MODIFICATIONS T THE MEDTRONIC CARELINK REMOTE HOME MONITOR AND MEDTRONIC CARDIOSIGH

NextDent Denture, E-Denture

FDA 510(k)

FDA Class 2 ·Dental

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2490G/H/J MEDTRONIC CARELINK MONITOR AND THE MODEL 2020A CARDIOSIGHT READER

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·Wallstent™ Venous Endoprosthesis with Unistep Plus™ Delivery System

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (VENOUS)