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4436
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3327
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2794
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468
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2431
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4114
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3833
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806
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793
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15
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1734
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883
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497
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7695
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167
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963
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4789
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1241
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System, Image Processing,...
730
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690
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568
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System, Imaging, Pulsed Doppler,...
535
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Powered Laser Surgical Instrument
520
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Prosthesis, Knee,...
493
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Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
431
MAX
Intervertebral Fusion Device...
406
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Mask, Surgical
400
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Manufacturers
BE
Agfa Healthcare N.V.
Medical Device Manufacturer
·
BE , Mortsel
Agfa Healthcare N.V. - FDA 510(k) Cleared Devices
27 submissions
·
27 cleared
·
Since 2009
27
Total
27
Cleared
0
Denied
26
devices
26-26 of 26
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1
2
Cleared
May 18, 2009
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
K090672
·
MQB
Radiology
·
66d
1
2
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27
Radiology
26
General & Plastic Surgery
1