510k
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469
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1406
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1108
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204
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829
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1856
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1338
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124
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86
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7
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422
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352
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2453
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48
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425
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2032
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144
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301
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298
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Electrosurgical, Cutting &...
258
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Automated Radiological Image...
255
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System, Imaging, Pulsed Doppler,...
245
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Plate, Fixation, Bone
242
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Polymer Patient Examination Glove
235
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Orthopedic Stereotaxic Instrument
200
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Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Bay Shore Medical Equipment Corp.
Medical Device Manufacturer
·
US , Bay Shore , NY
Bay Shore Medical Equipment Corp. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1989
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bay Shore Medical Equipment Corp.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 11, 1992
TEC1410 ANATOMICAL PROGRAMMING GENERATOR-MODIFICAT
K922814
·
IZO
Radiology
·
101d
Cleared
Nov 13, 1990
TEC 1410
K904397
·
IZO
Radiology
·
49d
Cleared
Nov 17, 1989
TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM
K892342
·
IZH
Radiology
·
226d
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3
Radiology
3