Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis

NEONATE-SINGLE--EHW-W/O CB

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Foxxmed Ltd·1 device

NEONATE-DUAL-EHW-W/O CB

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Foxxmed Ltd·1 device

ADULT-SINGLE-EHW-W/O CB

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Foxxmed Ltd·1 device

Closing Tool

FDA UDI

AMERICAN MEDICAL SYSTEMS, INC.·00878953000701·Closing Tool

Proximal Tool

FDA UDI

AMERICAN MEDICAL SYSTEMS, INC.·00878953003023·Proximal Cylinder Insertion Tool

Furlow Insertion Tool

FDA UDI

AMERICAN MEDICAL SYSTEMS, INC.·00878953000176·Cylinder Insertion Tool

Sterile, Single Use, Cataract Set CHw 2

Basic UDI-DI

EU MDD · Eu Md Class 2a ·HASA OPTIX·1 device

Sterile, Single Use, Cataract Set CHw 2

Basic UDI-DI

EU MDD · Eu Md Class 2a ·HASA OPTIX·1 device

Sterile, Single Use, Cataract Set CHw 1

Basic UDI-DI

EU MDD · Eu Md Class 2a ·HASA OPTIX·1 device

Sterile, Single Use, Cataract Set CHw 1

Basic UDI-DI

EU MDD · Eu Md Class 2a ·HASA OPTIX·1 device

KNEO

Basic UDI-DI

EU MDR · Eu Md Class 1 ·CHW-Technik GmbH·24 devices

Dynamische Schiene

Basic UDI-DI

EU MDR · Eu Md Class 1 ·CHW-Technik GmbH·7 devices

ARGOS

FDA 510(k)

FDA Class 2 ·Neurology

Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System

FDA 510(k)

FDA Class 2 ·Neurology

STRYKER NAV3I PLATFORM

FDA 510(k)

FDA Class 2 ·Neurology

neuromate Gen III

FDA 510(k)

FDA Class 2 ·Neurology

SmartFrame OR

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO FLOUROLAB PLUS

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000

FDA 510(k)

FDA Class 2 ·Neurology