510k
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Anesthesiology
3642
Cardiovascular
9905
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8609
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6108
Ear, Nose, Throat
1980
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5224
General & Plastic Surgery
8286
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6698
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1996
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2554
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16
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4822
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2944
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1869
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1458
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12412
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635
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1597
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8270
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2144
Categories
GEX
Powered Laser Surgical Instrument
1400
GEI
Electrosurgical, Cutting &...
1179
LLZ
System, Image Processing,...
1136
HRS
Plate, Fixation, Bone
944
LNH
System, Nuclear Magnetic...
818
IYN
System, Imaging, Pulsed Doppler,...
794
JWH
Prosthesis, Knee,...
788
ESD
Hearing Aid, Air-conduction,...
740
GCJ
Laparoscope, General & Plastic...
708
DZE
Implant, Endosseous, Root-form
695
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510k Database
Manufacturers
US
Amertek
Medical Device Manufacturer
·
US , Walker , MI
Amertek - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1981
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Amertek
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 08, 1982
CARDI-O-LIFE MODEL 8823
K821090
·
DPS
Cardiovascular
·
80d
Cleared
Dec 14, 1981
BLOOD PRESSURE MONITOR
K812936
·
DXN
Cardiovascular
·
55d
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Cardiovascular
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