510k
Database
Specialties
Anesthesiology
542
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1683
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370
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1341
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250
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979
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2201
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2052
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126
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99
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8
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472
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969
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436
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279
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2961
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52
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515
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2457
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
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Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
231
MAX
Intervertebral Fusion Device...
221
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Syntheon, LLC
Medical Device Manufacturer
·
US , Miami , FL
Syntheon, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2008
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Syntheon, LLC
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
Aug 30, 2023
LAA Exclusion System
K232295
·
PZX
Cardiovascular
·
29d
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2
Gastroenterology & Urology
1
Cardiovascular
1