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1034
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4329
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3210
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2787
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464
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2361
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3949
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3633
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786
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775
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15
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1404
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1755
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859
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492
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7536
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165
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961
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4605
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1237
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System, Image Processing,...
725
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689
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560
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System, Imaging, Pulsed Doppler,...
533
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Powered Laser Surgical Instrument
519
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Polymer Patient Examination Glove
489
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Prosthesis, Knee,...
464
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
392
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Manufacturers
US
Monobind
Medical Device Manufacturer
·
US , Mchenry , IL
Monobind - FDA 510(k) Cleared Devices
21 submissions
·
21 cleared
·
Since 1977
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Monobind
Immunology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 03, 1997
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834
·
JNL
Immunology
·
45d
Cleared
Jul 03, 1997
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
K971835
·
DDC
Immunology
·
45d
Cleared
Mar 22, 1978
T3 UPTAKE TEST
K780361
·
KHQ
Immunology
·
16d
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21
Chemistry
17
Immunology
3
Toxicology
1