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3600
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1718
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2253
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453
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2139
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3627
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3429
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444
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457
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15
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1173
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1624
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805
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473
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6400
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82
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698
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4159
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753
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System, Image Processing,...
705
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611
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Electrosurgical, Cutting &...
524
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Powered Laser Surgical Instrument
519
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System, Imaging, Pulsed Doppler,...
502
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Polymer Patient Examination Glove
483
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Intervertebral Fusion Device...
403
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Mask, Surgical
397
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Prosthesis, Knee,...
350
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Thoracolumbosacral Pedicle Screw...
347
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Manufacturers
US
Diamedix Corp.
Medical Device Manufacturer
·
US , Miami , FL
Diamedix Corp. - FDA 510(k) Cleared Devices
68 submissions
·
68 cleared
·
Since 1986
68
Total
68
Cleared
0
Denied
FDA 510(k) Regulatory Record - Diamedix Corp.
Chemistry
✕
5
devices
1-5 of 5
Filters
Cleared
Oct 09, 1997
MAGO AUTOMATED EIA PROCESSOR
K973177
·
JJF
Chemistry
·
45d
Cleared
Mar 16, 1989
TSH MICROASSAY
K890579
·
JLW
Chemistry
·
38d
Cleared
Feb 23, 1989
THYROXINE MICROASSAY
K884260
·
KLI
Chemistry
·
135d
Cleared
Feb 02, 1989
T-UPTAKE MICROASSAY
K885034
·
CEE
Chemistry
·
59d
Cleared
Dec 09, 1988
SERUM HCG MICROASSAY
K884430
·
DHA
Chemistry
·
49d
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68
Immunology
33
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30
Chemistry
5