510k
Database
Specialties
Anesthesiology
467
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1405
Chemistry
334
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1101
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203
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828
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1846
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1322
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124
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86
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7
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420
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788
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351
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224
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2452
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47
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421
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2025
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144
Categories
GEX
Powered Laser Surgical Instrument
300
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System, Image Processing,...
297
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Electrosurgical, Cutting &...
258
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Automated Radiological Image...
255
IYN
System, Imaging, Pulsed Doppler,...
244
HRS
Plate, Fixation, Bone
242
LZA
Polymer Patient Examination Glove
234
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
171
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Fixano SA
Medical Device Manufacturer
·
US , La Jolla , CA
Fixano SA - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2001
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fixano SA
Orthopedic
✕
5
devices
1-5 of 5
Filters
Cleared
Oct 18, 2002
MICROFIX
K023314
·
KTT
Orthopedic
·
45d
Cleared
Sep 23, 2002
TWIN FIX
K022771
·
KTT
Orthopedic
·
33d
Cleared
Sep 27, 2001
PF2
K012062
·
KTT
Orthopedic
·
87d
Cleared
Sep 27, 2001
RADIOFIX
K012078
·
KTT
Orthopedic
·
87d
Cleared
Aug 24, 2001
FLEX-NAILS
K012161
·
HTY
Orthopedic
·
44d
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5
Orthopedic
5