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4314
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3202
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2737
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464
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2293
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3560
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1404
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492
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958
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4597
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System, Image Processing,...
725
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689
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558
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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,...
461
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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
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Manufacturers
US
Streck
Medical Device Manufacturer
·
US , La Vista , NE
Streck - FDA 510(k) Cleared Devices
33 submissions
·
33 cleared
·
Since 2005
33
Total
33
Cleared
0
Denied
28
devices
26-28 of 28
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1
2
Cleared
Jan 13, 2006
CELL-CHEX AUTO
K053362
·
JPK
Hematology
·
42d
Cleared
Aug 17, 2005
IQ BODY FLUIDS CONTROL
K051706
·
JPK
Hematology
·
51d
Cleared
Aug 16, 2005
CD-CHEX PLUS BC
K051633
·
GGL
Hematology
·
57d
1
2
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33
Hematology
28
Microbiology
3
Chemistry
2