510k
Database
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Anesthesiology
538
Cardiovascular
1656
Chemistry
360
Dental
1323
Ear, Nose, Throat
244
Gastroenterology & Urology
957
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2176
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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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959
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433
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274
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2844
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52
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515
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2413
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
382
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
214
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St. Jude Medical (Now Abbott Medical)
Medical Device Manufacturer
·
US , St. Paul , MN
St. Jude Medical (Now Abbott Medical) - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - St. Jude Medical (Now Abbott Medical)
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 02, 2019
Ilumien Optis, Optis Integrated, Optis Mobile
K183320
·
NQQ
Cardiovascular
·
123d
Cleared
Feb 28, 2019
QUANTIEN Measurement System
K183099
·
DQK
Cardiovascular
·
113d
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Cardiovascular
2