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309
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953
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181
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1607
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114
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80
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Powered Laser Surgical Instrument
268
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256
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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
Hematology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 13, 2023
HemosIL Chromogenic Factor IX
K230852
·
GGP
Hematology
·
260d
Cleared
Jun 21, 2023
ACL TOP Family 70 Series
K231031
·
GKP
Hematology
·
71d
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3
Hematology
2
Chemistry
1