510k
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411
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1247
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309
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950
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181
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1604
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991
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113
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80
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402
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695
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303
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186
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2261
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43
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377
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1819
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138
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GEX
Powered Laser Surgical Instrument
266
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System, Image Processing,...
255
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Automated Radiological Image...
236
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System, Imaging, Pulsed Doppler,...
225
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Electrosurgical, Cutting &...
225
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Plate, Fixation, Bone
222
OLO
Orthopedic Stereotaxic Instrument
186
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Abutment, Implant, Dental,...
171
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Thoracolumbosacral Pedicle Screw...
154
MAX
Intervertebral Fusion Device...
149
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Medrad, Inc. / Bayer Medical Care, Inc.
Medical Device Manufacturer
·
US , Indianola , PA
Medrad, Inc. / Bayer Medical Care, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2013
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medrad, Inc. / Bayer Medical Care, Inc.
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 02, 2013
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
K131517
·
FPK
General Hospital
·
66d
Filters
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2
General Hospital
1
Cardiovascular
1