510k
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1290
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325
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985
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185
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758
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1662
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117
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82
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408
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726
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316
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194
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2340
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390
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1880
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139
Categories
GEX
Powered Laser Surgical Instrument
278
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System, Image Processing,...
263
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Automated Radiological Image...
246
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Electrosurgical, Cutting &...
231
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Plate, Fixation, Bone
230
IYN
System, Imaging, Pulsed Doppler,...
230
OLO
Orthopedic Stereotaxic Instrument
191
NHA
Abutment, Implant, Dental,...
178
LZA
Polymer Patient Examination Glove
165
NKB
Thoracolumbosacral Pedicle Screw...
159
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Pioneer Surgical Technology
Medical Device Manufacturer
·
US , Marquette , MI
Pioneer Surgical Technology - FDA 510(k) Cleared Devices
50 submissions
·
48 cleared
·
Since 1993
50
Total
48
Cleared
0
Denied
FDA 510(k) Regulatory Record - Pioneer Surgical Technology
General & Plastic Surgery
✕
1
devices
1-1 of 1
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Cleared
Sep 19, 1997
PIONEER ELEC-TROCAR DEVICE
K971728
·
GEI
General & Plastic Surgery
·
133d
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50
Orthopedic
48
Neurology
1
General & Plastic Surgery
1