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6533
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15070
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11372
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10147
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2837
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7894
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14262
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12379
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2667
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3175
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20
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6004
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4924
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3347
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3067
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16903
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894
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3162
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12980
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2672
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GEX
Powered Laser Surgical Instrument
2442
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System, Image Processing,...
2079
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Electrosurgical, Cutting &...
1953
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Implant, Endosseous, Root-form
1334
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Plate, Fixation, Bone
1293
GCJ
Laparoscope, General & Plastic...
1146
IYN
System, Imaging, Pulsed Doppler,...
1142
LZA
Polymer Patient Examination Glove
1104
LNH
System, Nuclear Magnetic...
1006
HWC
Screw, Fixation, Bone
992
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510k Database
Manufacturers
US
Positron
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Medical Device Manufacturer
·
US , Mchenry , IL
Positron - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1981
Official Website
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Positron
Radiology
✕
3
devices
1-3 of 3
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Cleared
Jul 08, 1993
POSICAM-HZ & POSICAM-HZL
K926206
·
KPS
Radiology
·
211d
Cleared
May 09, 1991
POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM
K911275
·
KPS
Radiology
·
48d
Cleared
Nov 02, 1989
MODIFIED POSICAM SYSTEM MODEL 6.5
K894998
·
KPS
Radiology
·
86d
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4
Radiology
3
Ear, Nose, Throat
1