510k
Database
Specialties
Anesthesiology
542
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1683
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370
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1341
Ear, Nose, Throat
250
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978
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2199
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2052
Hematology
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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2952
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52
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515
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2455
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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
228
MAX
Intervertebral Fusion Device...
220
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Swims America Corp
Medical Device Manufacturer
·
US , White Plains , NY
Swims America Corp - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Swims America Corp
Physical Medicine
✕
1
devices
1-1 of 1
Filters
Cleared
Sep 14, 2023
BACK 4
K230167
·
IPF
Physical Medicine
·
237d
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4
General & Plastic Surgery
3
Physical Medicine
1