510k
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327
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1009
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190
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1705
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117
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83
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412
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734
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321
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199
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2372
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393
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1903
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141
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Powered Laser Surgical Instrument
281
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267
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Automated Radiological Image...
246
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241
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232
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Plate, Fixation, Bone
232
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Orthopedic Stereotaxic Instrument
194
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Abutment, Implant, Dental,...
180
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Polymer Patient Examination Glove
171
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Intervertebral Fusion Device...
163
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American Mammographics, Inc.
Medical Device Manufacturer
·
US , Chattanooga , TN
American Mammographics, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1990
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Mammographics, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 13, 2002
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
K023229
·
IZH
Radiology
·
77d
Cleared
Oct 24, 1995
MAMMOSPOT PADDLE
K954521
·
IZH
Radiology
·
26d
Cleared
Nov 15, 1990
AMI MAMMOSPOT
K903651
·
IZH
Radiology
·
97d
Cleared
Nov 15, 1990
MAMMOSPOT 3 AND MAMMOSPOT 8
K904517
·
IZH
Radiology
·
43d
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4
Radiology
4