MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASTRAGUARD PULMONARY FUNCTION FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STS SHIELD WITH MASK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

A-1000 EEG MONITOR AND A-1050 EEG MONITOR

FDA 510(k)

FDA Class 2 ·Neurology

NC-STAT

FDA 510(k)

FDA Class 2 ·Neurology

CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TAMPER PROOF CAP

FDA 510(k)

FDA Class 2 ·General Hospital

binx health io CT/NG Assay

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICROSURGE LASER FIBER WITH SMA CONNECTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE FIBER OPTIC DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PULPDENT GLAZE

FDA 510(k)

FDA Class 2 ·Dental

TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES

FDA 510(k)

FDA Class 2 ·Orthopedic