510k
Database
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Anesthesiology
429
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1302
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327
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1003
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188
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775
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1692
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1095
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117
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83
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7
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411
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730
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318
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198
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2358
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44
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393
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1893
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140
Categories
GEX
Powered Laser Surgical Instrument
280
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System, Image Processing,...
267
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Automated Radiological Image...
246
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Electrosurgical, Cutting &...
239
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System, Imaging, Pulsed Doppler,...
231
HRS
Plate, Fixation, Bone
231
OLO
Orthopedic Stereotaxic Instrument
193
NHA
Abutment, Implant, Dental,...
180
LZA
Polymer Patient Examination Glove
170
MAX
Intervertebral Fusion Device...
161
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Ebi, L.P.
Medical Device Manufacturer
·
US , Parsippany , NJ
Ebi, L.P. - FDA 510(k) Cleared Devices
95 submissions
·
94 cleared
·
Since 1997
95
Total
94
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ebi, L.P.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 19, 2005
ACUMEN IMAGE GUIDED SURGICAL SYSTEM
K051724
·
HAW
Neurology
·
22d
Cleared
Oct 15, 2003
EBI ACUMEN SURGICAL NAVIGATION SYSTEM
K031732
·
HAW
Neurology
·
133d
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Orthopedic
91
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2
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