BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INSTRUMED LAPAROSCOPE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ISIS MER SYSTEM/ELEKTA MER SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799

FDA 510(k)

FDA Class 2 ·Neurology

ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE ONLINE TDM PHENYTOIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES

ARCHITECT STAT CK-MB IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

ORAJEL ADVANCED TOOTH DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION

FDA 510(k)

FDA Class 2 ·Dental

ARCHITECT STAT TROPONIN-1; MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT STAT MYO IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT STAT TROPONIN-I IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHILI PACS

FDA 510(k)

FDA Class 2 ·Radiology

MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic