510k
Database
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Anesthesiology
550
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1727
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386
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1399
Ear, Nose, Throat
257
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994
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2237
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2094
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127
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104
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8
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474
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985
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444
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286
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3075
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52
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515
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2509
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156
Categories
LZA
Polymer Patient Examination Glove
419
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
366
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
312
IYN
System, Imaging, Pulsed Doppler,...
305
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
237
MAX
Intervertebral Fusion Device...
234
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Fix Surgical
Medical Device Manufacturer
·
US , Conshohocken , PA
Fix Surgical - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fix Surgical
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
May 15, 2024
Augment Off-Axis Instrument System
K241043
·
PHX
Orthopedic
·
28d
Cleared
Mar 22, 2024
Augment Off-Axis Instrument System
K233148
·
PHX
Orthopedic
·
177d
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Orthopedic
2