510k
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538
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1654
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360
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1323
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243
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957
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2175
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2038
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126
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97
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8
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462
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958
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
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System, Image Processing,...
381
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358
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Powered Laser Surgical Instrument
351
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301
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
275
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Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Amplify Surgical, Inc.
Medical Device Manufacturer
·
US , Laguna Hills , CA
Amplify Surgical, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2019
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Amplify Surgical, Inc.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 18, 2022
DualXSLIM(R) T/PLIF
K222203
·
MAX
Orthopedic
·
85d
Cleared
Sep 29, 2021
DualX
K211740
·
MAX
Orthopedic
·
114d
Cleared
Oct 15, 2019
DualX Lumbar Intervertebral Body Fusion Device
K192434
·
MAX
Orthopedic
·
40d
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3
Orthopedic
3