510k
Database
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Anesthesiology
133
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568
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163
Dental
313
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68
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287
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515
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372
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67
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56
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232
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165
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61
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49
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1292
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18
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85
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868
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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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Pro3dure Medical GmbH
Medical Device Manufacturer
·
DE , Iserlohn
Pro3dure Medical GmbH - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2020
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Pro3dure Medical GmbH
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 08, 2022
Thermeo System
K212017
·
MQC
Dental
·
284d
Cleared
Oct 21, 2021
GR Splint Resin System
K211415
·
MQC
Dental
·
168d
Cleared
May 05, 2021
GR-14 Resin System
K210298
·
EBI
Dental
·
91d
Cleared
Nov 05, 2020
GR-17 Resin System
K201827
·
EBG
Dental
·
126d
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4
Dental
4