CARDIO IV/GXT STRESS TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

VARIANT II B-THALASSEMIA

FDA 510(k)

FDA Class 2 ·Hematology

COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.

FDA 510(k)

FDA Class 2 ·Hematology

IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMPLATZ MOVEABLE CORE GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AIRWAY BALLOON CATHETER INFLATION DEVICE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS

FDA 510(k)

FDA Class 2 ·Dental

MEROGEL OTOLOGIC PACK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PTCA STEERABLE HYDROPHILIC GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT

FDA 510(k)

FDA Class 2 ·Radiology

COALESCENT SURGICAL U-CLIP AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PORT-O-SCOPE(TM)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COMPUSTRESS STRESS TESTING SYS

FDA 510(k)

FDA Class 2 ·Cardiovascular

OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HILUX LEDMAX 3

FDA 510(k)

FDA Class 2 ·Dental

BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

cryoFORM cryoICE cryoablation probe

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QuantumCam

FDA 510(k)

FDA Class 2 ·Radiology