Panther Fusion AdV/hMPV/RV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

t:slim X2 Insulin Pump with Interoperable Technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Hypertension Prediction Index (HePI) Algorithm

FDA 510(k)

FDA Class 2 ·Cardiovascular

KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE

FDA 510(k)

FDA Class 2 ·Immunology

COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ALDERSON BREST DOSIMETRY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CIRRUS HD-OCT

FDA 510(k)

FDA Class 2 ·Ophthalmic

Aspida® Anterior Lumbar Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

Catalys Precision Laser System

FDA 510(k)

FDA Class 2 ·Ophthalmic

t:slim X2 Insulin Pump with Interoperable Technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SSV PHONATE(TM) SHILEY SPEAKING VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

da Vinci Xi Surgical System, da Vinci X Surgical System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Aria System

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: T-PORT HP INFUSION PORT

FDA 510(k)

FDA Class 2 ·General Hospital

IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry