510k
Database
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Anesthesiology
462
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1395
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334
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1089
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200
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826
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1828
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1298
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124
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85
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7
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420
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781
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350
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220
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2446
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47
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417
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2018
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144
Categories
GEX
Powered Laser Surgical Instrument
298
LLZ
System, Image Processing,...
294
GEI
Electrosurgical, Cutting &...
256
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Automated Radiological Image...
253
IYN
System, Imaging, Pulsed Doppler,...
243
HRS
Plate, Fixation, Bone
241
LZA
Polymer Patient Examination Glove
226
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
169
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Highgate Orthopaedics
Medical Device Manufacturer
·
US , Chesterland , OH
Highgate Orthopaedics - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2002
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Highgate Orthopaedics
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 22, 2003
MODIFICATION TO HIGHGATE CURVED ROD SYSTEM
K023983
·
KWQ
Orthopedic
·
294d
Cleared
Mar 12, 2002
HIGHGATE CURVED ROD SYSTEM
K012045
·
KWQ
Orthopedic
·
256d
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Orthopedic
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