MYHEALTHPOINT TELEHEALTH MANAGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

OnSite Waste Sharps Container

FDA 510(k)

FDA Class 2 ·General Hospital

Cysto-Gastro-Sets

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOTIM Patient Cushion Immobilization System

FDA 510(k)

FDA Class 2 ·Radiology

MyGlucoHealth Wireless System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETEST Fosfomycin (FO) (0.032-512 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

LIAC S

FDA 510(k)

FDA Class 2 ·Radiology

SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

SYMPHONY DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Natus Quantum

FDA 510(k)

FDA Class 2 ·Neurology

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

MERITS WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS

FDA 510(k)

FDA Class 2 ·Hematology

SignalMark Lung Biopsy Site Marker

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Platypus

FDA UDI

Inspiration G5 LLC dba PlatypusCo·00858813002038·Platypus T103 Patient Sample Pack includes 75 3...

Hubly Electric Drill

FDA UDI

Hubly, Inc. DBA Hubly Surgical·00860007807411·Hubly Electric Drill and Accessory Kit - With D...

Hubly Electric Drill

FDA UDI

Hubly, Inc. DBA Hubly Surgical·00860007807404·Hubly Electric Drill - Drill only

Hubly Electric Drill

FDA UDI

Hubly, Inc. DBA Hubly Surgical·00860007807428·Hubly Electric Drill and Accessory Kit - Withou...

LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·EXABLATE 2000