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689
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533
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519
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Polymer Patient Examination Glove
489
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464
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Intervertebral Fusion Device...
403
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400
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Screw, Fixation, Bone
392
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Manufacturers
US
Iriderm Div.
Medical Device Manufacturer
·
US , Mountain View , CA
Iriderm Div. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1989
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Iriderm Div.
Ophthalmic
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 28, 1996
OCULIGHT GL
K960971
·
HQF
Ophthalmic
·
170d
Cleared
Jul 19, 1996
DIOPEXY PROBE
K960522
·
HQF
Ophthalmic
·
164d
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10
General & Plastic Surgery
8
Ophthalmic
2