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3632
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9905
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8609
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6095
Ear, Nose, Throat
1975
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5224
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8286
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6697
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1996
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2553
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16
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4822
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2942
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1869
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1458
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12396
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635
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1597
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8269
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2144
Categories
GEX
Powered Laser Surgical Instrument
1400
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Electrosurgical, Cutting &...
1179
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System, Image Processing,...
1136
HRS
Plate, Fixation, Bone
944
LNH
System, Nuclear Magnetic...
818
IYN
System, Imaging, Pulsed Doppler,...
794
JWH
Prosthesis, Knee,...
787
ESD
Hearing Aid, Air-conduction,...
740
GCJ
Laparoscope, General & Plastic...
708
DZE
Implant, Endosseous, Root-form
689
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510k Database
Manufacturers
US
Namic
Medical Device Manufacturer
·
US , Walker , MI
Namic - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 1979
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Namic
General Hospital
✕
1
devices
1-1 of 1
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Cleared
Jul 09, 1993
MORSE ANESTHESIA MANIFOLD
K921322
·
FPA
General Hospital
·
484d
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8
Cardiovascular
7
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1