510k
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542
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1683
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369
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1339
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249
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978
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2198
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2048
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126
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99
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8
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470
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965
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436
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279
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2944
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52
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515
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2448
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
388
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358
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Powered Laser Surgical Instrument
356
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306
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
279
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Automated Radiological Image...
276
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Orthopedic Stereotaxic Instrument
227
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Intervertebral Fusion Device...
220
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Formlabs Ohio, Inc.
Medical Device Manufacturer
·
US , Millbury , OH
Formlabs Ohio, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Formlabs Ohio, Inc.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 19, 2024
Premium Teeth Resin
K240538
·
EBG
Dental
·
144d
Cleared
Feb 16, 2024
Dental LT Comfort Resin
K232087
·
MQC
Dental
·
218d
Cleared
Nov 10, 2022
Dental LT Clear V2 Resin
K222061
·
MQC
Dental
·
120d
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3
Dental
3