510k
Database
Specialties
Anesthesiology
525
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1613
Chemistry
356
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1304
Ear, Nose, Throat
237
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934
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2142
General Hospital
2009
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126
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91
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8
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458
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942
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429
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272
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2757
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52
Physical Medicine
515
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2354
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
406
LLZ
System, Image Processing,...
374
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,...
271
HRS
Plate, Fixation, Bone
268
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Alafair Biosciences, Inc.
Medical Device Manufacturer
·
US , Austin , TX
Alafair Biosciences, Inc. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2016
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alafair Biosciences, Inc.
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 02, 2023
VersaWrap Nerve Protector
K232029
·
JXI
Neurology
·
118d
Cleared
Sep 14, 2020
VersaWrap Nerve Protector
K201631
·
JXI
Neurology
·
90d
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7
General & Plastic Surgery
3
Neurology
2
Orthopedic
2