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Ear, Nose, Throat
2016
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510k Database
Manufacturers
US
Bioform, Inc.
Medical Device Manufacturer
·
US , Franksville , WI
Bioform, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2001
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bioform, Inc.
Ear, Nose, Throat
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 12, 2003
LARYNGEAL AUGMENTATION IMPLANT
K033398
·
MIX
Ear, Nose, Throat
·
49d
Cleared
Jan 09, 2002
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
K013243
·
KHJ
Ear, Nose, Throat
·
103d
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4
Ear, Nose, Throat
2
Dental
1
General & Plastic Surgery
1