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4923
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3620
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2818
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475
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2514
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4256
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3897
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15
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1933
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1844
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893
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498
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8226
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187
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978
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System, Image Processing,...
757
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696
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System, Imaging, Pulsed Doppler,...
609
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Electrosurgical, Cutting &...
571
GEX
Powered Laser Surgical Instrument
523
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Prosthesis, Knee,...
522
LZA
Polymer Patient Examination Glove
489
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System, Nuclear Magnetic...
475
MAX
Intervertebral Fusion Device...
444
NKB
Thoracolumbosacral Pedicle Screw...
438
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Manufacturers
US
Isotis NV
Medical Device Manufacturer
·
US , North Attleboro , MA
Isotis NV - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2000
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Isotis NV
General Hospital
✕
1
devices
1-1 of 1
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Cleared
Jul 16, 2004
OPEN BORE SYRINGE
K041344
·
FMF
General Hospital
·
57d
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8
Orthopedic
4
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3
General Hospital
1