510k
Database
Specialties
Anesthesiology
525
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1626
Chemistry
356
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1304
Ear, Nose, Throat
237
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941
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2148
General Hospital
2015
Hematology
126
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91
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8
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458
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946
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430
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272
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2758
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52
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515
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2356
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
374
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Nanofiber Solutions, LLC
Medical Device Manufacturer
·
US , Hilliard , OH
Nanofiber Solutions, LLC - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2019
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nanofiber Solutions, LLC
Orthopedic
✕
5
devices
1-5 of 5
Filters
Cleared
Feb 27, 2025
Rotium
K250021
·
OWW
Orthopedic
·
55d
Cleared
Jul 29, 2024
BIOCHARGE
K241912
·
MAI
Orthopedic
·
28d
Cleared
Jul 05, 2023
Rotium Bioresorbable Wick
K231641
·
MAI
Orthopedic
·
30d
Cleared
Jun 25, 2020
Rotium Bioresorbable Wick
K201414
·
MAI
Orthopedic
·
27d
Cleared
Mar 11, 2019
Rotium Bioresorbable Wick
K183236
·
MAI
Orthopedic
·
111d
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Orthopedic
5