510k
Database
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Anesthesiology
132
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568
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163
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313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
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513
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371
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67
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56
Medical Genetics
0
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232
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163
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61
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49
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1291
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Abmrc, LLC
Medical Device Manufacturer
·
US , Charleston , SC
Abmrc, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Abmrc, LLC
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 08, 2024
BiWaze Clear System
K231728
·
NHJ
Anesthesiology
·
300d
Cleared
Dec 21, 2022
BiWaze Clear System
K213564
·
NHJ
Anesthesiology
·
407d
Cleared
Mar 27, 2020
BiWaze Cough
K191912
·
NHJ
Anesthesiology
·
254d
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3
Anesthesiology
3