510k
Database
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Anesthesiology
735
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2253
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488
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1803
Ear, Nose, Throat
317
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1295
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2810
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2523
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159
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140
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13
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597
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1256
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591
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386
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3934
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61
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606
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3131
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177
Categories
LLZ
System, Image Processing,...
530
LZA
Polymer Patient Examination Glove
459
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Powered Laser Surgical Instrument
445
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Electrosurgical, Cutting &...
404
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Mask, Surgical
388
IYN
System, Imaging, Pulsed Doppler,...
376
HRS
Plate, Fixation, Bone
361
MAX
Intervertebral Fusion Device...
316
OLO
Orthopedic Stereotaxic Instrument
292
QIH
Automated Radiological Image...
286
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Manufacturers
US
Quantimetrix Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Quantimetrix Corp. - FDA 510(k) Cleared Devices
38 submissions
·
38 cleared
·
Since 1983
38
Total
38
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Jul 18, 1983
SPINAL FLUID TOTAL PROTEIN CONTROL
K831527
·
JJX
Chemistry
·
67d
Cleared
Jul 07, 1983
SALICYLATE ASSAY KIT
K831336
·
DKJ
Chemistry
·
73d
1
2
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38
Chemistry
27
Toxicology
7
Hematology
2
Immunology
2