510k
Database
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Anesthesiology
549
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1720
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385
Dental
1378
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252
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982
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2219
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2088
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127
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101
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8
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474
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981
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441
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283
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3048
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52
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515
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2497
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155
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LZA
Polymer Patient Examination Glove
416
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System, Image Processing,...
401
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Powered Laser Surgical Instrument
363
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359
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Electrosurgical, Cutting &...
309
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System, Imaging, Pulsed Doppler,...
304
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Plate, Fixation, Bone
297
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Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Envisiontec GmbH
Medical Device Manufacturer
·
DE , Gladbeck
Envisiontec GmbH - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2020
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Envisiontec GmbH
Dental
✕
5
devices
1-5 of 5
Filters
Cleared
Jun 10, 2022
SmileGuard
K220894
·
MQC
Dental
·
74d
Cleared
Jun 14, 2021
E-Temp
K211101
·
EBG
Dental
·
62d
Cleared
May 25, 2021
E-Dent 1000
K210977
·
EBF
Dental
·
54d
Cleared
Mar 30, 2021
E-Denture Pro
K203641
·
EBI
Dental
·
106d
Cleared
Nov 27, 2020
E-Guard
K201173
·
MQC
Dental
·
210d
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5
Dental
5