510k
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411
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1242
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309
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940
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180
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728
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1593
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988
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113
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80
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6
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400
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692
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298
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184
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2246
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43
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371
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1813
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138
Categories
GEX
Powered Laser Surgical Instrument
261
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System, Image Processing,...
255
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Automated Radiological Image...
236
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System, Imaging, Pulsed Doppler,...
224
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Electrosurgical, Cutting &...
222
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Plate, Fixation, Bone
220
OLO
Orthopedic Stereotaxic Instrument
184
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
152
MAX
Intervertebral Fusion Device...
149
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Biomet Manufactuting Corp.
Medical Device Manufacturer
·
US , Warsaw , IN
Biomet Manufactuting Corp. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biomet Manufactuting Corp.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 29, 2014
G7 Finned Acetabular Shell
K142746
·
LPH
Orthopedic
·
96d
Cleared
Nov 20, 2012
COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
K123297
·
MBF
Orthopedic
·
29d
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Orthopedic
2