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3210
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2789
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465
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4059
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3725
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788
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776
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15
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7541
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165
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963
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725
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689
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568
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533
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Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
464
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
392
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Manufacturers
US
Synthes
Medical Device Manufacturer
·
US , Paoli , PA
Synthes - FDA 510(k) Cleared Devices
11 submissions
·
11 cleared
·
Since 1998
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Synthes
Neurology
✕
2
devices
1-2 of 2
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Cleared
Sep 05, 2013
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
K123723
·
GWO
Neurology
·
275d
Cleared
Jan 09, 2012
SYNTHECEL DURA REPLACEMENT DEVICES
K113071
·
GXQ
Neurology
·
84d
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9
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2