510k
Database
Specialties
Anesthesiology
542
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1680
Chemistry
365
Dental
1338
Ear, Nose, Throat
249
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974
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2194
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2047
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126
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99
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8
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469
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965
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433
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279
Orthopedic
2937
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52
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515
Radiology
2444
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Sorin Biomedica, Fiat, USA, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Sorin Biomedica, Fiat, USA, Inc. - FDA 510(k) Cleared Devices
20 submissions
·
20 cleared
·
Since 1980
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sorin Biomedica, Fiat, USA, Inc.
Toxicology
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 24, 1980
DIGOCTK 125
K800773
·
LCS
Toxicology
·
17d
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20
Chemistry
9
Cardiovascular
9
Toxicology
1
Anesthesiology
1