510k
Database
Specialties
Anesthesiology
548
Cardiovascular
1718
Chemistry
381
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1364
Ear, Nose, Throat
252
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982
General & Plastic Surgery
2217
General Hospital
2088
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126
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101
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8
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474
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980
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441
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283
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3046
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52
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515
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2492
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155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
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Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
297
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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First Source, Inc.
Medical Device Manufacturer
·
US , Rochester , NY
First Source, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2021
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - First Source, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 03, 2024
iQFlex Pro
K240009
·
IZL
Radiology
·
183d
Cleared
Jun 13, 2022
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
K221081
·
IZL
Radiology
·
62d
Cleared
Mar 24, 2021
I-Q View
K203703
·
MQB
Radiology
·
96d
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3
Radiology
3