510k
Database
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204
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739
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187
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465
Ear, Nose, Throat
91
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394
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771
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475
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77
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64
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1
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277
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300
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116
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78
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1476
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26
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152
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1088
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93
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IYN
System, Imaging, Pulsed Doppler,...
167
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Plate, Fixation, Bone
151
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Orthopedic Stereotaxic Instrument
130
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Powered Laser Surgical Instrument
126
LLZ
System, Image Processing,...
123
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Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
105
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Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
NKB
Thoracolumbosacral Pedicle Screw...
93
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Alphamed, Inc.
Medical Device Manufacturer
·
US , Duluth , GA
Alphamed, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1993
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Alphamed, Inc.
Ophthalmic
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 24, 2019
Tear Pool Dissolvable Punctum Plugs
K190210
·
LZU
Ophthalmic
·
262d
Cleared
Oct 23, 2009
ALPHAMED SURGICAL SPEAR, MODEL 70-5000
K091240
·
HOZ
Ophthalmic
·
179d
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4
Ophthalmic
2
Anesthesiology
1
General Hospital
1