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309
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181
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1607
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114
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Powered Laser Surgical Instrument
268
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256
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Automated Radiological Image...
237
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226
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Electrosurgical, Cutting &...
225
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Plate, Fixation, Bone
223
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Orthopedic Stereotaxic Instrument
187
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Abutment, Implant, Dental,...
171
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Thoracolumbosacral Pedicle Screw...
154
LZA
Polymer Patient Examination Glove
153
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Instrumentation Laboratory Company
Medical Device Manufacturer
·
US , Bedford , MA
Instrumentation Laboratory Company - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2023
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Instrumentation Laboratory Company
Chemistry
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 10, 2023
GEM Premier 7000 with IQM3
K223608
·
CHL
Chemistry
·
251d
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3
Hematology
2
Chemistry
1