510k
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334
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1121
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209
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836
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1882
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1403
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125
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87
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2468
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48
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430
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2052
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145
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Powered Laser Surgical Instrument
305
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System, Image Processing,...
304
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Polymer Patient Examination Glove
266
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260
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Automated Radiological Image...
255
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System, Imaging, Pulsed Doppler,...
245
HRS
Plate, Fixation, Bone
243
OLO
Orthopedic Stereotaxic Instrument
203
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Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Ebi Electro Biology
Medical Device Manufacturer
·
US , Parsippany , NJ
Ebi Electro Biology - FDA 510(k) Cleared Devices
3 submissions
·
1 cleared
·
Since 1997
3
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ebi Electro Biology
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Aug 13, 1999
EBI OMEGA 21 SYSTEM
K991721
·
MNI
Orthopedic
·
85d
Cleared
Jan 13, 1998
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K973923
·
KWQ
Orthopedic
·
90d
Cleared
Dec 24, 1997
OMEGA 21 SYSTEM
K973683
·
MNH
Orthopedic
·
89d
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3
Orthopedic
3