Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES EXPRESS ULTRASONOMETER

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·ACHILLES INSIGHT ULTRASONOMETER

Quick-20m

FDA 510(k)

FDA Class 2 ·Neurology

AMEDITECH DRUGSMARTCUP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COMPACS, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

AURADORM (NEUROMUSCULAR SLEEP)

FDA 510(k)

FDA Class 2 ·Dental

FLEXCATH STEERABLE SHEATH & DILATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEGVISION, MODEL EQ1000C SERIES

FDA 510(k)

FDA Class 2 ·Neurology

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODEL 515 NEONATAL MONIOTR

Catheter, Biliary, Reprocessed

FDA classification

FDA Class 2 ·Catheter, Biliary, Reprocessed

Electrophoretic, Lactate Dehydrogenase Isoenzymes

FDA classification

FDA Class 2 ·Electrophoretic, Lactate Dehydrogenase Isoenzymes

System, Water Jet Catheter, Renal

FDA classification

FDA Class 2 ·System, Water Jet Catheter, Renal

MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

M-60 GOLD BASE DENTAL ALLOY

FDA 510(k)

FDA Class 2 ·Dental

ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER

FDA 510(k)

FDA Class 2 ·General Hospital

TYCHE PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

IPL hair removal device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CALCIUM REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry