510k
Database
Specialties
Anesthesiology
540
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1660
Chemistry
362
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1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
General & Plastic Surgery
2177
General Hospital
2039
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126
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97
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8
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462
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960
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433
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274
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2846
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52
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515
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2417
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
288
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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Advanced Surgical Concepts, Ltd.
Medical Device Manufacturer
·
IE , Bray
Advanced Surgical Concepts, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
1 cleared
·
Since 2016
3
Total
1
Cleared
2
Denied
FDA 510(k) Regulatory Record - Advanced Surgical Concepts, Ltd.
Obstetrics & Gynecology
✕
1
devices
1-1 of 1
Filters
Not Cleared
Apr 07, 2016
PneumoLiner
DEN150028
·
PMU
Obstetrics & Gynecology
·
293d
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3
General & Plastic Surgery
2
Obstetrics & Gynecology
1