510k
Database
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Anesthesiology
542
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1680
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365
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1338
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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
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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
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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 &...
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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Innovative Health
Medical Device Manufacturer
·
US , Scottsdale , AZ
Innovative Health - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Innovative Health
Cardiovascular
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 07, 2026
Reprocessed Agilis NxT Steerable Introducer
K250305
·
PNE
Cardiovascular
·
338d
Cleared
Jun 07, 2024
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K233825
·
NLH
Cardiovascular
·
189d
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Cardiovascular
2