510k
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Anesthesiology
440
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1343
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331
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1036
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192
Gastroenterology & Urology
796
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1757
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1168
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118
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84
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7
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414
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751
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331
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205
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2401
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44
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402
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1942
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141
Categories
GEX
Powered Laser Surgical Instrument
287
LLZ
System, Image Processing,...
277
GEI
Electrosurgical, Cutting &...
249
QIH
Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
234
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
190
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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Problem Solving Concepts, Inc.
Medical Device Manufacturer
·
US , Indianapolis , IN
Problem Solving Concepts, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2000
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Problem Solving Concepts, Inc.
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
Dec 17, 2002
PROSOLV CARDIVASCULAR VIEWER
K023112
·
DQK
Cardiovascular
·
89d
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2
Radiology
1
Cardiovascular
1