510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
Gastroenterology & Urology
978
General & Plastic Surgery
2199
General Hospital
2050
Hematology
126
Immunology
99
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8
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471
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966
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436
Ophthalmic
279
Orthopedic
2949
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52
Physical Medicine
515
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2454
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
280
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Nextgen Biologics, Inc.
Medical Device Manufacturer
·
US , Gainesville , FL
Nextgen Biologics, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2018
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nextgen Biologics, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 07, 2021
NeoMatriX Wound Matrix
K210024
·
KGN
General & Plastic Surgery
·
276d
Cleared
Oct 11, 2018
NeoMatriX Wound Matrix
K181330
·
KGN
General & Plastic Surgery
·
146d
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2
General & Plastic Surgery
2