510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1337
Ear, Nose, Throat
248
Gastroenterology & Urology
972
General & Plastic Surgery
2194
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2047
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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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433
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275
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2923
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52
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515
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2442
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155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
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Mask, Surgical
358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Indiba S. A. U.
Medical Device Manufacturer
·
ES , Sant Quirze Del Vall?s (Barcelona)
Indiba S. A. U. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2024
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Indiba S. A. U.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 24, 2025
Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY )
K241107
·
PBX
General & Plastic Surgery
·
277d
Cleared
Jan 22, 2025
Reverso Pro System
K243139
·
GEI
General & Plastic Surgery
·
114d
Cleared
Nov 20, 2024
INDIBA COMPACT devices
K243164
·
PBX
General & Plastic Surgery
·
51d
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3
General & Plastic Surgery
3