510k
Database
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Anesthesiology
474
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1435
Chemistry
336
Dental
1130
Ear, Nose, Throat
210
Gastroenterology & Urology
839
General & Plastic Surgery
1891
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1432
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125
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87
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8
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426
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811
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361
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236
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2472
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49
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437
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2059
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145
Categories
GEX
Powered Laser Surgical Instrument
307
LLZ
System, Image Processing,...
304
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Polymer Patient Examination Glove
275
GEI
Electrosurgical, Cutting &...
260
QIH
Automated Radiological Image...
256
IYN
System, Imaging, Pulsed Doppler,...
246
HRS
Plate, Fixation, Bone
244
OLO
Orthopedic Stereotaxic Instrument
203
NHA
Abutment, Implant, Dental,...
191
MAX
Intervertebral Fusion Device...
171
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Labsonics, Inc.
Medical Device Manufacturer
·
US , Mooresville , IN
Labsonics, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 1988
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Labsonics, Inc.
Obstetrics & Gynecology
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 04, 1988
ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
K872265
·
HGL
Obstetrics & Gynecology
·
207d
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2
Obstetrics & Gynecology
1
Radiology
1