510k
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134
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569
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164
Dental
314
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68
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289
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520
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373
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67
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56
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0
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233
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167
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61
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49
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1293
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18
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86
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870
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88
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IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
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Orthopedic Stereotaxic Instrument
117
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System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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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) cleared devices by 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