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1697
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117
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2365
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1898
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281
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267
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246
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232
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231
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Orthopedic Stereotaxic Instrument
194
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Abutment, Implant, Dental,...
180
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Polymer Patient Examination Glove
170
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Thoracolumbosacral Pedicle Screw...
161
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Amertek Medical, Inc.
Medical Device Manufacturer
·
US , Singer Island , FL
Amertek Medical, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2001
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Amertek Medical, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 15, 2003
AMERITEK SURE-POINT HDR NEEDLE TEMPLATE
K031273
·
JAQ
Radiology
·
84d
Cleared
May 20, 2003
AMERITEK SURE-POINT TRACKER SYSTEM
K030518
·
ITX
Radiology
·
90d
Cleared
Jul 17, 2001
AMERITEK BRACHYTHERAPY TEMPLATE
K011581
·
ITX
Radiology
·
55d
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3
Radiology
3