510k
Database
Specialties
Anesthesiology
542
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1680
Chemistry
365
Dental
1338
Ear, Nose, Throat
249
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975
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2196
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2048
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126
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99
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8
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469
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965
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434
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279
Orthopedic
2940
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52
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515
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2444
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
306
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
278
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Abanza Tecnomed S.L
Medical Device Manufacturer
·
ES , Mutilva
Abanza Tecnomed S.L - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abanza Tecnomed S.L
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 06, 2026
QuadLock™ Fixation System
K253618
·
MBI
Orthopedic
·
49d
Cleared
Feb 25, 2025
WasherCap™ Fixation System
K250238
·
MBI
Orthopedic
·
29d
Cleared
Jan 30, 2025
WasherCap™ Mini Fixation System (Model 45)
K243712
·
MBI
Orthopedic
·
59d
Cleared
Sep 22, 2022
WasherCap Fixation System
K212197
·
MBI
Orthopedic
·
435d
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Orthopedic
4