MISCELLANEOUS PANEL

FDA UDI

UTAK LABORATORIES, INC.·B800MPUFLSA0·MISCELLANEOUS PANEL

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II Left Ventricular Assist System (LVAS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit

MedibinoNEO cover GOTS organic cotton with hotel closure - Size M - PU 6

Device

EU MDR · Eu Md Class 1 ·Kluba Medical GmbH·On the market

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)

MedibinoNEO inner pillow, WWL 200 filled with soft granulat - Size M - PU 6

Device

EU MDR · Eu Md Class 1 ·Kluba Medical GmbH·On the market

MedibinoNEO disposable cover cotton knit WITH soft granules - colour coded - Size M - PU 50

Device

EU MDR · Eu Md Class 1 ·Kluba Medical GmbH·On the market

MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - colour coded - Size M - PU 50

Device

EU MDR · Eu Md Class 1 ·Kluba Medical GmbH·On the market

MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - colour coded - Size M PU 5

Device

EU MDR · Eu Md Class 1 ·Kluba Medical GmbH·On the market

MedibinoNEO ring – TG PUR Gel, outer material biocompatible PU film - Size M - PU 6

Device

EU MDR · Eu Md Class 1 ·Kluba Medical GmbH·On the market·2 countries

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EXTERNAL PULSE GENERATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PREVAIL

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEGEND PLUS FAMILY OF PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC & INSYNC III CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III AT ICD