510k
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1268
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311
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963
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181
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114
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80
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2303
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379
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1846
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GEX
Powered Laser Surgical Instrument
272
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System, Image Processing,...
256
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Automated Radiological Image...
242
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System, Imaging, Pulsed Doppler,...
227
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Electrosurgical, Cutting &...
227
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Plate, Fixation, Bone
226
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Orthopedic Stereotaxic Instrument
188
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Abutment, Implant, Dental,...
175
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Thoracolumbosacral Pedicle Screw...
156
LZA
Polymer Patient Examination Glove
155
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Medical Design, LLC
Medical Device Manufacturer
·
US , Brandon , SD
Medical Design, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2002
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medical Design, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 15, 2012
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR...
K122497
·
KWQ
Orthopedic
·
60d
Cleared
Aug 20, 2012
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA...
K121148
·
HWC
Orthopedic
·
126d
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3
Orthopedic
2
Neurology
1