510k
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540
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362
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1334
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245
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963
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2186
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2043
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126
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97
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8
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466
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433
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274
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2886
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52
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515
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2431
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Polymer Patient Examination Glove
408
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384
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358
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353
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302
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System, Imaging, Pulsed Doppler,...
296
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Automated Radiological Image...
276
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Plate, Fixation, Bone
270
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Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Maxigen Biotech, Inc.
Medical Device Manufacturer
·
US , Flagstaff , AZ
Maxigen Biotech, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2011
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Maxigen Biotech, Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 16, 2025
SurgiAid Collagen Wound Dressing (HA)
K242100
·
KGN
General & Plastic Surgery
·
455d
Cleared
Oct 11, 2023
SurgiAid® Collagen Wound Dressing
K223126
·
KGN
General & Plastic Surgery
·
373d
Cleared
Feb 02, 2011
SURGIAID
K100927
·
KGN
General & Plastic Surgery
·
303d
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4
General & Plastic Surgery
3
Dental
1