510k
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426
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1285
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318
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978
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184
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755
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1651
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1058
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116
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82
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408
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718
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316
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194
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2325
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43
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388
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1869
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139
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GEX
Powered Laser Surgical Instrument
276
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System, Image Processing,...
260
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Automated Radiological Image...
244
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System, Imaging, Pulsed Doppler,...
230
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Plate, Fixation, Bone
229
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Electrosurgical, Cutting &...
228
OLO
Orthopedic Stereotaxic Instrument
191
NHA
Abutment, Implant, Dental,...
177
LZA
Polymer Patient Examination Glove
161
NKB
Thoracolumbosacral Pedicle Screw...
159
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Synthes, Inc.
Medical Device Manufacturer
·
US , 19380 , PA
Synthes, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2011
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Synthes, Inc.
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 26, 2011
SYNTHES STERNAL FIXATION SYSTEM
K112689
·
HRS
Orthopedic
·
41d
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8
Dental
5
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1
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1
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1