TALON DISTALFIX PROXIMAL FEMORAL NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

D.L. SCOPE(R) OTOSCOPE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

D.L. SCOPE BLADE & HANDLE

FDA 510(k)

FDA Class 1 ·Anesthesiology

CYBER-LASE 2000 CURING AND WHITENING LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital

SAFE-SITE NEEDLE COVER

FDA 510(k)

FDA Class 2 ·General Hospital

VACUETTE WITH PPACK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Cannulated Compression Device System

FDA 510(k)

FDA Class 2 ·Orthopedic

ETEST FOR AMPICILLIN/SULBACTAM 2/1

FDA 510(k)

FDA Class 2 ·Microbiology

EASY-CURE (CURING AND WHITENING LIGHT)

FDA 510(k)

FDA Class 2 ·Dental

CHALLENGE TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

Talon DistalFix Antegrade/Retrograde Femoral Nail

FDA 510(k)

FDA Class 2 ·Orthopedic

NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (DUAL SPECIES) NAMSA BIOLOGICAL INDICATOR SPORE STRIPS (SINGLE SPECIES)

FDA 510(k)

FDA Class 2 ·General Hospital

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·NMP22 BLADDERCHEK TEST KIT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

EosSpec-STERILE

Basic UDI-DI

EU MDR · Eu Md Class 1 ·NORTH EOS INDUSTRIES,INC.·24 devices

NasalSpec

Basic UDI-DI

EU MDR · Eu Md Class 1 ·NORTH EOS INDUSTRIES,INC.·30 devices

DentSpec

Basic UDI-DI

EU MDR · Eu Md Class 1 ·NORTH EOS INDUSTRIES,INC.·4 devices

EyelidSpec

Basic UDI-DI

EU MDR · Eu Md Class 1 ·NORTH EOS INDUSTRIES,INC.·1 device