Planmed Verity

FDA 510(k)

FDA Class 2 ·Radiology

ULTRA BEAUTY

FDA 510(k)

FDA Class 2 ·Neurology

Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SOFT (HYDROPHILIC) CONTACT LENSES

FDA 510(k)

FDA Class 2 ·Ophthalmic

SKYLINE 55

FDA 510(k)

FDA Class 2 ·Cardiovascular

Toothsi, Smilealigners

FDA 510(k)

FDA Class 2 ·Dental

AUTODELFIA NEONATAL IRT KIT, MODEL B005-112

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Neorad Pacs (Neorad Pacs)

FDA 510(k)

FDA Class 2 ·Radiology

CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Surgify Halo

FDA 510(k)

FDA Class 2 ·Neurology

Nouvo Safety Set

FDA 510(k)

FDA Class 2 ·General Hospital

qER-Quant

FDA 510(k)

FDA Class 2 ·Radiology

Cardiovascular Angiography System

FDA 510(k)

FDA Class 2 ·Radiology

DELFIA DIGOXIN KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Planmeca ProMax 3D Max, Planmeca Maximity

FDA 510(k)

FDA Class 2 ·Radiology

cNeuro cDAT

FDA 510(k)

FDA Class 2 ·Radiology

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

FDA 510(k)

FDA Class 2 ·Dental

RESUBMITTED SCANORA

FDA 510(k)

FDA Class 2 ·Radiology

Bindex BI-2

FDA 510(k)

FDA Class 2 ·Radiology

INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE

FDA 510(k)

FDA Class 2 ·Orthopedic