510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1683
Chemistry
370
Dental
1341
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
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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967
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436
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279
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2955
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52
Physical Medicine
515
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2457
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
391
FXX
Mask, Surgical
358
GEX
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
229
MAX
Intervertebral Fusion Device...
221
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Tamabio
Medical Device Manufacturer
·
JP , Tokyo
Tamabio - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Tamabio
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 18, 2025
PeriBeam® Pericardial Membrane
K240775
·
DXZ
Cardiovascular
·
393d
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1
Cardiovascular
1