ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209

FDA 510(k)

FDA Class 2 ·Immunology

MODIFIED KEYMED FLEXIBLE ESOPHAGEAL DILATORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OLYMPUS SUCTION PUMP MODEL KV-4

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206

FDA 510(k)

FDA Class 2 ·Immunology

Irrigation Tubing with CO2 or Air

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

Red Dot

FDA 510(k)

FDA Class 2 ·Radiology

HOTWIRE™ RF Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

OLYMPUS SUCTION PUMP, MODEL KV-5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE

FDA 510(k)

FDA Class 2 ·Ophthalmic

OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Test, Sorbent, Fta-Abs

FDA classification

FDA Class 2 ·Test, Sorbent, Fta-Abs

SABA Tampons

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Myoglobin, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Myoglobin, Fitc, Antigen, Antiserum, Control

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