510k
Database
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141
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581
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167
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324
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68
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296
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536
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384
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67
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58
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234
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173
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68
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52
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1303
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18
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88
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888
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
136
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Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Apelem-Dms Group
Medical Device Manufacturer
·
US , Ashland , MA
Apelem-Dms Group - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2013
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Apelem-Dms Group
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 22, 2021
Platinum dRF Imaging System
K203010
·
JAA
Radiology
·
113d
Cleared
Mar 04, 2016
Platinum dRF Imaging System
K160301
·
JAA
Radiology
·
29d
Cleared
Dec 12, 2013
PLATINUM DRF IMAGING SYSTEM
K131766
·
JAA
Radiology
·
178d
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3
Radiology
3