510k
Database
Specialties
Anesthesiology
519
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1600
Chemistry
356
Dental
1297
Ear, Nose, Throat
234
Gastroenterology & Urology
927
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2126
General Hospital
1959
Hematology
126
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91
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8
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449
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938
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425
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271
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2691
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52
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511
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2316
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
401
LLZ
System, Image Processing,...
366
GEX
Powered Laser Surgical Instrument
349
FXX
Mask, Surgical
337
GEI
Electrosurgical, Cutting &...
293
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
261
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
205
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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) Regulatory Record - 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