BonOs Inject, Pedicle screw kits, Cement pusher

FDA 510(k)

FDA Class 2 ·Orthopedic

REVOIS PRO IMPLANT STSYEM

FDA 510(k)

FDA Class 2 ·Dental

BonOs HV Genta, BonOs MV Genta, BonOs LV Genta

FDA 510(k)

FDA Class 2 ·Orthopedic

Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ICE Ceramics, ICE Stains, Fresco

FDA 510(k)

FDA Class 2 ·Dental

Primum Hydrophilic Guiding Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Prettau, ICE, Z-White zirconia blanks

FDA 510(k)

FDA Class 2 ·Dental

RIDA GENE Norovirus GI/GII

FDA 510(k)

FDA Class 2 ·Microbiology

Color Liquid, Vita Liquid

FDA 510(k)

FDA Class 2 ·Dental

ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

FDA 510(k)

FDA Class 2 ·Radiology

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

FDA 510(k)

FDA Class 2 ·Dental

SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS

FDA 510(k)

FDA Class 2 ·Radiology

PINNACLE MAGNETIC RESONANCE IMAGING SCANNER

FDA 510(k)

FDA Class 2 ·Radiology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFT MATE(R) HYDROGEN PEROXIDE DISINFECTION SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ORACLE(TM) CORONARY BALLOON DILATATION CATHETER

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·SOFTLENS CLEANING & DISINFECTING SOLN.

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS FRESH(TM) LUBRICATING & REWETTING SOLN

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST

System, Nuclear Magnetic Resonance Imaging

FDA Pre-Market Approval

FDA Class 2 ·FONAR NMR WHOLE BODY SCANNER BETA 3000

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·RIGID GAS PERMEABLE CONTACT LENSES