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4436
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3258
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2794
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468
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2431
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4114
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3832
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805
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782
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1726
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883
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497
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167
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963
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730
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690
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568
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535
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Powered Laser Surgical Instrument
520
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
485
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System, Nuclear Magnetic...
431
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Intervertebral Fusion Device...
406
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Mask, Surgical
400
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Manufacturers
US
Hygeia Sciences
Medical Device Manufacturer
·
US , Newton , MA
Hygeia Sciences - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1986
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hygeia Sciences
Microbiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jun 02, 1988
HYGEIA GC TEST
K881064
·
LIR
Microbiology
·
80d
Cleared
Jun 25, 1986
HYGEIA RAPID STREP A TEST
K862133
·
GTY
Microbiology
·
21d
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4
Chemistry
2
Microbiology
2