Infinity Gateway Suite

FDA 510(k)

FDA Class 2 ·Cardiovascular

HEART STG SYSTEM AND SOFTWARE

FDA 510(k)

FDA Class 2 ·Cardiovascular

NMI 2.8 MICROCATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTRODUCER SHEATH AND DILATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMAPROMPT

FDA 510(k)

FDA Class 2 ·Hematology

HEMAGEN ENA [JO-1] KIT (EIA METHOD)

FDA 510(k)

FDA Class 2 ·Immunology

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

EASYLYTE SODIUM/POTASSIUM/LITHIUM ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BONE BLOCK FIXATION SET

FDA 510(k)

FDA Class 2 ·Dental

CRW-1 SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

POC ARTHROSCOPE AND ACCESSORIES

FDA 510(k)

FDA Class 2 ·Orthopedic

EndoArmor™ + Surgical Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EQUALIZER BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LONG TERM PERITONEAL CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MASSTRAK IMMUNOSUPPRESSANTS KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VSPSPN

FDA 510(k)

FDA Class 2 ·Orthopedic

MODUS SAGITTAL SPLIT PLATE

FDA 510(k)

FDA Class 2 ·Dental

EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery