510k
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1612
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356
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235
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2135
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1991
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126
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91
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449
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515
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155
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Polymer Patient Examination Glove
403
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368
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357
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351
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Electrosurgical, Cutting &...
295
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Automated Radiological Image...
273
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System, Imaging, Pulsed Doppler,...
264
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Plate, Fixation, Bone
262
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Orthopedic Stereotaxic Instrument
218
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Abutment, Implant, Dental,...
205
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Facet Technologies, LLC
Medical Device Manufacturer
·
US , Kennesaw , GA
Facet Technologies, LLC - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2014
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Facet Technologies, LLC
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 29, 2014
CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT
K141749
·
FMI
General Hospital
·
29d
Cleared
May 13, 2014
CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT
K140568
·
FMI
General Hospital
·
69d
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7
General & Plastic Surgery
5
General Hospital
2