NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

JEL BIOS 90 (CODE NAME RD-2401)

FDA 510(k)

FDA Class 2 ·Dental

BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

Bio-Medicus Life Support Catheter and Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

MODEL 9300 TREND ANALYZING BIO-MONITOR SYS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Blue Sky Bio Computerized Orthodontic Bracket System

FDA 510(k)

FDA Class 2 ·Dental

HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO TENS 601, 606 AND 608 (3000)

FDA 510(k)

FDA Class 2 ·Neurology

CHEMICAL INDICATOR - KEM MED & BIO SURE

FDA 510(k)

FDA Class 2 ·General Hospital

BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIO-OSS PURE NAT HYDROXYAPATITE ENDOSS IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-MED CORP. DISP. NON-STERILE TRANSDU

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIO-RAY A-1 Anchor Screw System

FDA 510(k)

FDA Class 2 ·Dental

ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry