System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)

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

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

ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS

FDA 510(k)

FDA Class 2 ·Radiology

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM