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No Description
Synapse Biomedical, Inc.
20-0074
In Commercial Distribution
- 00852184003618 ()
- Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Synapse Biomedical, Inc.
21-0039-99
In Commercial Distribution
- 00852184003588 ()
- Intramuscular diaphragm/phrenic nerve electrical stimulation system
Software Pristina 9 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.9
In Commercial Distribution
- 10195278901764 ()
- Mammographic x-ray system stereotactic unit
- Stationary mammographic x-ray system, digital
MANTA 14F Depth Locator
ESSENTIAL MEDICAL, INC.
IPN928169
In Commercial Distribution
- 10856279007366 ()
- 00856279007369 ()
- Catheter Gauge: 14 French
114F
- Femoral artery closure plug/patch, collagen
MANTA 8F Depth Locator
ESSENTIAL MEDICAL, INC.
IPN928168
In Commercial Distribution
- 10856279007342 ()
- 00856279007345 ()
- Catheter Gauge: 8 French
188F
- Femoral artery closure plug/patch, collagen
14F MANTA Vascular Closure Device
ESSENTIAL MEDICAL, INC.
IPN928167
In Commercial Distribution
- 10856279007328 ()
- 00856279007321 ()
- Catheter Gauge: 14 French
2156
- Femoral artery closure plug/patch, collagen
No Description
ESSENTIAL MEDICAL, INC.
114F
In Commercial Distribution
- 00856279007215 ()
- 00856279007208 ()
- Femoral artery closure plug/patch, collagen
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
BATTERY, LPCR2
PHYSIO-CONTROL, INC.
11141
In Commercial Distribution
- 00883873871560 ()
11141-000163
- Scalpel, single-use
Edwards EVOQUE Tricuspid Delivery System
Edwards Lifesciences LLC
9850TDSUS
In Commercial Distribution
- 00690103217520 ()
9850TDSUS
- Tricuspid transcatheter heart valve bioprosthesis