510k
Database
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542
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1338
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249
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975
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2196
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2048
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126
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99
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469
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434
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279
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2940
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52
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515
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2444
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155
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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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Electrosurgical, Cutting &...
306
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
278
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Automated Radiological Image...
276
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Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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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) Regulatory Record - 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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Dental
4