510k
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Anesthesiology
438
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1336
Chemistry
329
Dental
1032
Ear, Nose, Throat
192
Gastroenterology & Urology
793
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1749
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1154
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117
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84
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7
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413
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746
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329
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204
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2393
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44
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400
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1930
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141
Categories
GEX
Powered Laser Surgical Instrument
285
LLZ
System, Image Processing,...
275
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Electrosurgical, Cutting &...
248
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Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
235
HRS
Plate, Fixation, Bone
232
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
185
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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Odin Technologies , Ltd.
Medical Device Manufacturer
·
IL , Yokneam Elit
Odin Technologies , Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1999
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Odin Technologies , Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 20, 2000
POLESTAR N-10
K002242
·
LNH
Radiology
·
58d
Cleared
Jun 18, 1999
NORMA 10
K991243
·
LNH
Radiology
·
67d
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2
Radiology
2