510k
Database
Specialties
Anesthesiology
525
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1612
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
928
General & Plastic Surgery
2135
General Hospital
1991
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126
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91
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8
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449
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942
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429
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272
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2704
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52
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515
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2334
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155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
370
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
266
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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NanoHive Medical, LLC
Medical Device Manufacturer
·
US , Woburn , MA
NanoHive Medical, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
Official Website
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - NanoHive Medical, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 13, 2026
Hive™ Standalone Cervical System and Hive™ C Interbody System
K254105
·
ODP
Orthopedic
·
56d
Cleared
Jul 12, 2023
NanoHive Medical Lumbar Interbody System
K231241
·
MAX
Orthopedic
·
75d
Cleared
Dec 12, 2022
Hive™ Standalone Cervical System
K223190
·
OVE
Orthopedic
·
60d
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3
Orthopedic
3