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HeartLight X3 Console, US
CARDIOFOCUS, INC.
18-4952
In Commercial Distribution
- 00859373007440 ()
18-4952
- Cardiac ablation solid-state laser system
HeartLight X3 Disposable Motor Catheter
CARDIOFOCUS, INC.
18-5000
In Commercial Distribution
- 00859373007433 ()
- Catheter Gauge: 12 French
18-5000
- Cardiac ablation laser system beam guide-catheter
BATTERY, LPCR2
PHYSIO-CONTROL, INC.
11141
In Commercial Distribution
- 00883873871560 ()
11141-000163
- Scalpel, single-use
Cellex Procedural Kit U.S.
THERAKOS, INC.
CLXUSA
In Commercial Distribution
- 00705030000050 ()
CLXUSA
- Photopheresis system blood set
CellEX Procedural Kit RoHS 3 Correct Connect (US)
THERAKOS, INC.
CLXCC-U
In Commercial Distribution
- 30705030000037 ()
- 00705030000036 ()
CLXCC-U
- Photopheresis system blood set
CellEX Procedural Kit RoHS 3 Correct Connect (OUS)
THERAKOS, INC.
CLXCC-I
In Commercial Distribution
- 00705030000029 ()
- 30705030000020 ()
CLXCC-I
- Photopheresis system blood set
CellEx Procedural Kit
THERAKOS, INC.
CLXSP-I
In Commercial Distribution
- 30705030000006 ()
- 00705030000005 ()
CLXSP-I
- Photopheresis system blood set
The intended use for the ML6710i laser is photoactivation of VISUDYNE® (verteporfin for injection), which is a light-activated drug used in photodynamic therapy (PDT) for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.
Please consult the VISUDYNE® (Bausch & Lomb Incorporated) prescribing information for additional information on intended use, recommended drug and light dose, administration instructions, contraindications, warnings and precautions, and side effects of VISUDYNE® treatment.
Modulight Oyj
ML6710i
In Commercial Distribution
- 06429810677020 ()
- Ophthalmic diode laser system
Edwards EVOQUE Tricuspid Delivery System
Edwards Lifesciences LLC
9850TDSUS
In Commercial Distribution
- 00690103217520 ()
9850TDSUS
- Tricuspid transcatheter heart valve bioprosthesis
PASCAL PRECISION SYSTEM - GUIDE SHEATH
Edwards Lifesciences LLC
20000GSA
In Commercial Distribution
- 00690103216967 ()
20000GSA
- Heart valve clip