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

cortiQ PRO

FDA 510(k)

FDA Class 2 ·Neurology

Ceramill A-Temp

FDA 510(k)

FDA Class 2 ·Dental

Proxeo ULTRA (PB-510, PB-520 and PB-530)

FDA 510(k)

FDA Class 2 ·Dental

mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ECG-ELECTRODE(SWAROMED)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Eating Disorder Conditioning Tool

FDA classification

FDA Class 2 ·Eating Disorder Conditioning Tool

Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·CLERZ LUBRICATING & REWETTING EYE DROPS