510k
Database
Specialties
Anesthesiology
531
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1642
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359
Dental
1316
Ear, Nose, Throat
242
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954
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2166
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2031
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126
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97
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8
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462
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951
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433
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274
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2828
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52
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515
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2401
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155
Categories
LZA
Polymer Patient Examination Glove
407
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System, Image Processing,...
380
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357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
299
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System, Imaging, Pulsed Doppler,...
283
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Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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Elevate Oral Care
Medical Device Manufacturer
·
US , West Palm Beach , FL
Elevate Oral Care - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2013
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Elevate Oral Care
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Feb 27, 2026
Allday Moisturizing Rinse
K253778
·
LFD
Dental
·
93d
Cleared
Jul 18, 2024
Papacarie Duo
K233768
·
LBH
Dental
·
237d
Cleared
Jun 19, 2015
Elevate Moisturizing Spray
K150074
·
LFD
Dental
·
156d
Cleared
Aug 27, 2013
SMARTCOAT 2.5% NAF VARNISH
K131376
·
LBH
Dental
·
105d
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4
Dental
4