510k
Database
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Anesthesiology
534
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1646
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359
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1323
Ear, Nose, Throat
243
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956
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2174
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2038
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126
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97
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8
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462
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953
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433
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274
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2828
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52
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515
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2403
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
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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...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Systam
Medical Device Manufacturer
·
US , Elfers , FL
Systam - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 1998
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Systam
Anesthesiology
✕
1
devices
1-1 of 1
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Cleared
Dec 22, 1998
LS SERIES 200 FLOVISION SYSTEM
K971981
·
CAF
Anesthesiology
·
572d
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Anesthesiology
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