510k
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550
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1727
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386
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1394
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256
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992
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2235
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2093
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127
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104
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474
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985
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444
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286
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3071
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52
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515
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2508
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156
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LZA
Polymer Patient Examination Glove
418
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System, Image Processing,...
401
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Powered Laser Surgical Instrument
366
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359
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310
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System, Imaging, Pulsed Doppler,...
305
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Plate, Fixation, Bone
299
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Automated Radiological Image...
277
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Orthopedic Stereotaxic Instrument
236
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Intervertebral Fusion Device...
234
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Seriously Clean, Ltd.
Medical Device Manufacturer
·
US , Nixa , MO
Seriously Clean, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Seriously Clean, Ltd.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
May 02, 2025
Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel
K243457
·
FRO
General & Plastic Surgery
·
176d
Cleared
Dec 11, 2012
NIXALL TM WOUND AND SKIN CARE
K113693
·
FRO
General & Plastic Surgery
·
361d
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General & Plastic Surgery
2