510k
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Anesthesiology
411
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1250
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309
Dental
950
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181
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738
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1606
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994
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113
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80
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6
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402
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695
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303
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186
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2261
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43
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377
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1824
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138
Categories
GEX
Powered Laser Surgical Instrument
267
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System, Image Processing,...
255
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Automated Radiological Image...
237
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Electrosurgical, Cutting &...
225
IYN
System, Imaging, Pulsed Doppler,...
225
HRS
Plate, Fixation, Bone
222
OLO
Orthopedic Stereotaxic Instrument
186
NHA
Abutment, Implant, Dental,...
171
NKB
Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
150
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Fulcrum Medical, Inc.
Medical Device Manufacturer
·
US , Chesterfield , MO
Fulcrum Medical, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2010
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fulcrum Medical, Inc.
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Oct 29, 2010
FULACCESS MODEL 1.0
K101707
·
LLZ
Radiology
·
134d
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Radiology
1