PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEGA LUMBAR PUNCTURE KIT

FDA 510(k)

FDA Class 2 ·General Hospital

20G SMA LASER FIBER, MODEL LF100

FDA 510(k)

FDA Class 2 ·Ophthalmic

OLYMPIC LIGHT-WARM

FDA 510(k)

FDA Class 1 ·General Hospital

SOFTLASE G2-SURGICAL DIODE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIGGY AGAR

FDA 510(k)

FDA Class 1 ·Microbiology

Pleurx Pleural Catheter System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Passio Pump Drainage System

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BRAIN PORT

FDA 510(k)

FDA Class 2 ·Neurology

MTF NEW BONE VOID FILLER

FDA 510(k)

FDA Class 2 ·Orthopedic

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

COOLSKIN

FDA 510(k)

FDA Class 2 ·Physical Medicine

CDMX

FDA 510(k)

FDA Class 2 ·Dental

Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)

FDA 510(k)

FDA Class 2 ·Physical Medicine

ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

INCISION AND DRAINAGE KIT

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology