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3201
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2735
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463
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2287
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3847
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System, Image Processing,...
725
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671
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539
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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,...
431
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Intervertebral Fusion Device...
403
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Mask, Surgical
400
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Screw, Fixation, Bone
386
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Manufacturers
BE
Terumo Europe N.V.
Medical Device Manufacturer
·
BE , Leuven
Terumo Europe N.V. - FDA 510(k) Cleared Devices
28 submissions
·
28 cleared
·
Since 1999
28
Total
28
Cleared
0
Denied
27
devices
26-27 of 27
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1
2
Cleared
Aug 14, 2000
NEOLUS NEEDLE
K001572
·
FMI
General Hospital
·
84d
Cleared
Jun 14, 1999
K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE...
K984576
·
FMI
General Hospital
·
173d
1
2
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28
General Hospital
27
Chemistry
1