PRESSURIZED INFUSION PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN™ and WATCHMAN FLX™ Left Atrial Appendage Closure Devices with Delivery Systems

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System

Spine Needle (16 Gauge)

FDA UDI

ELLIQUENCE, LLC·00846338008017·

Spine Needle (18 Gauge)

FDA UDI

ELLIQUENCE, LLC·00846338000776·

Force DFX Suture

FDA UDI

DUNAMIS MEDICAL, LLC·00854629006482·Force DFX Suture™ #2 (UHMWPE) 36" HC-5 1/2 Circ...

Force DFX Suture

FDA UDI

DUNAMIS MEDICAL, LLC·00854629006499·Force DFX Suture™ #5 (UHMWPE) 36" HS48 1/2 Circ...

CS 9300C

FDA UDI

CARESTREAM HEALTH, INC.·60889975210964·CS 9300C 230V R

Omni

FDA UDI

GE MEDICAL SYSTEMS, INC.·00195278454218·OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY

CS 9300C

FDA UDI

CARESTREAM HEALTH, INC.·60889975210988·CS 9300C 230V

CS 9300C

FDA UDI

CARESTREAM HEALTH, INC.·60889975319698·CS 9300C 230V

Discovery

FDA UDI

GE MEDICAL SYSTEMS, INC.·00840682125703·

Discovery

FDA UDI

GE MEDICAL SYSTEMS, INC.·00840682146166·

CS 8100SC 3D

FDA UDI

CARESTREAM DENTAL LLC·60192155500114·CS 8100SC 3D

Discovery

FDA UDI

GE MEDICAL SYSTEMS, INC.·00840682103107·

Discovery

FDA UDI

GE MEDICAL SYSTEMS, INC.·00840682108218·

O560 to D600 Upgrade

FDA UDI

GE MEDICAL SYSTEMS, INC.·00840682143981·

Omni

FDA UDI

G E MEDICAL SYSTEMS ISRAEL LTD.·00195278592309·OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY