510k
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550
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1723
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386
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1385
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256
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990
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2226
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2093
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127
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104
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474
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985
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443
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285
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3058
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52
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515
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2503
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156
Categories
LZA
Polymer Patient Examination Glove
418
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401
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363
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359
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310
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System, Imaging, Pulsed Doppler,...
304
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Plate, Fixation, Bone
298
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Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
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Intervertebral Fusion Device...
233
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Eusa Pharma (Uk) Limited
Medical Device Manufacturer
·
GB , Hemel Hempstead
Eusa Pharma (Uk) Limited - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Eusa Pharma (Uk) Limited
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 11, 2024
Caphosol® Artifical Saliva (32 doses sachet box)
K234015
·
LFD
Dental
·
83d
Cleared
Mar 31, 2017
Caphosol Artifical Saliva Tablets
K162167
·
LFD
Dental
·
240d
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Dental
2