AXON-BUS PROSTHETIC SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ImagingRing System

FDA 510(k)

FDA Class 2 ·Radiology

MEDILOGAR4, MEDILOGAR12

FDA 510(k)

FDA Class 2 ·Cardiovascular

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Wi-3 HAL-RAR System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SECTOR TRANSDUCER MODEL NO. AWP3.5/A

FDA 510(k)

FDA Class 2 ·Radiology

Task Force CORE

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROMATE

FDA 510(k)

FDA Class 2 ·Radiology

I.T.S. Hand Locking Plates System - HLS

FDA 510(k)

FDA Class 2 ·Orthopedic

eMurmur ID

FDA 510(k)

FDA Class 2 ·Cardiovascular

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Encevis

FDA 510(k)

FDA Class 2 ·Neurology

I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)

FDA 510(k)

FDA Class 2 ·Orthopedic

Bonebridge

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

g.Nautilus PRO

FDA 510(k)

FDA Class 2 ·Neurology

eMurmur Heart AI

FDA 510(k)

FDA Class 2 ·Cardiovascular

Micromate™ Navi+

FDA 510(k)

FDA Class 2 ·Radiology

DIMERTEST LATEX

FDA 510(k)

FDA Class 2 ·Hematology