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980
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3810
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2675
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2468
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454
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2200
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3651
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1216
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System, Image Processing,...
705
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669
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524
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Powered Laser Surgical Instrument
519
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System, Imaging, Pulsed Doppler,...
502
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Polymer Patient Examination Glove
483
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Prosthesis, Knee,...
431
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Intervertebral Fusion Device...
403
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Mask, Surgical
398
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Screw, Fixation, Bone
383
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Manufacturers
FR
Osyris
Medical Device Manufacturer
·
FR , Hellemmes
Osyris - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2008
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osyris
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 26, 2008
SMOOTHKIT+
K082004
·
GEX
General & Plastic Surgery
·
74d
Cleared
Jul 17, 2008
PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
K080731
·
GEX
General & Plastic Surgery
·
125d
Cleared
Apr 09, 2008
PHARAON LIPO
K073617
·
GEX
General & Plastic Surgery
·
105d
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3
General & Plastic Surgery
3