510k
Database
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Anesthesiology
553
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1736
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387
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1407
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258
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997
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2244
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2105
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127
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105
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8
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477
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988
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452
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286
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3087
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52
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517
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2517
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156
Categories
LZA
Polymer Patient Examination Glove
423
LLZ
System, Image Processing,...
402
GEX
Powered Laser Surgical Instrument
366
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Mask, Surgical
361
GEI
Electrosurgical, Cutting &...
313
IYN
System, Imaging, Pulsed Doppler,...
306
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
238
MAX
Intervertebral Fusion Device...
235
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HC Biologics, LLC
Medical Device Manufacturer
·
US , Miami , FL
HC Biologics, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
Official Website
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - HC Biologics, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 13, 2026
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK...
K260340
·
ODP
Orthopedic
·
70d
Cleared
Mar 27, 2025
HC Biologics Osteopoint Spinal Fixation System
K250092
·
NKB
Orthopedic
·
72d
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Orthopedic
2