COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600

FDA 510(k)

FDA Class 2 ·Cardiovascular

STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Continuous Single Culture -NX (CSCM-NX)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE

FDA 510(k)

FDA Class 2 ·Radiology

HURWITZ DIALYSIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD

FDA 510(k)

FDA Class 2 ·Cardiovascular

SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]

FDA 510(k)

FDA Class 2 ·Cardiovascular

LASER SYSTEM YELLOWSTAR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLAME PHOTOMETER STANDARD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

MDx-Chex for BC-GN

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Warrior Control Panel M290

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire RP2.1/RP2.1plus Control Panel M441

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert GBS LB Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray RP EZ Control Panel M265

FDA 510(k)

FDA Class 2 ·Microbiology