510k
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1738
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387
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1407
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258
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1005
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2252
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2110
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127
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105
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478
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995
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458
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287
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3096
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518
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2527
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Categories
LZA
Polymer Patient Examination Glove
424
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System, Image Processing,...
404
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370
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361
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313
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System, Imaging, Pulsed Doppler,...
307
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Plate, Fixation, Bone
300
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Automated Radiological Image...
277
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Orthopedic Stereotaxic Instrument
241
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Intervertebral Fusion Device...
235
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Manufacturers
US
Osteomed
Medical Device Manufacturer
·
US , Addison , TX
Osteomed - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 2012
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osteomed
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 04, 2017
OsteoMed PINNACLE Driver
K162544
·
KMW
Dental
·
204d
Cleared
Sep 21, 2015
OsteoMed IMF Screw
K151195
·
DZL
Dental
·
140d
Cleared
Dec 18, 2014
OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM
K140978
·
JEY
Dental
·
246d
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12
Orthopedic
6
Dental
3
Neurology
3