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1092
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4436
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3258
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2794
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468
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2431
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4114
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3832
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805
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782
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15
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1726
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1772
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883
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497
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7672
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167
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963
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4789
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1239
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System, Image Processing,...
730
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Plate, Fixation, Bone
690
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Electrosurgical, Cutting &...
568
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System, Imaging, Pulsed Doppler,...
535
GEX
Powered Laser Surgical Instrument
520
LZA
Polymer Patient Examination Glove
489
JWH
Prosthesis, Knee,...
485
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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
US
Porex Medical
Medical Device Manufacturer
·
US , Mchenry , IL
Porex Medical - FDA 510(k) Cleared Devices
15 submissions
·
15 cleared
·
Since 1983
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Porex Medical
Ophthalmic
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 27, 1987
POREX(TM) EYE SPHERE IMPLANT
K863943
·
HPZ
Ophthalmic
·
140d
Cleared
Feb 27, 1987
POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT
K863946
·
HQX
Ophthalmic
·
140d
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15
General & Plastic Surgery
11
Ear, Nose, Throat
2
Ophthalmic
2