510k
Database
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Anesthesiology
134
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569
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165
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318
Ear, Nose, Throat
68
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289
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524
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375
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67
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57
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0
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234
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172
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62
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51
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1295
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18
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87
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871
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
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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Timpel S.A.
Medical Device Manufacturer
·
BR , Sao Paulo
Timpel S.A. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Timpel S.A.
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Sep 10, 2025
Enlight 2100 (TPL-E2103-0)
K250464
·
QEB
Anesthesiology
·
204d
Cleared
Mar 07, 2023
Enlight 2100
K222897
·
QEB
Anesthesiology
·
165d
Cleared
Jan 06, 2022
Enlight 2100
K211135
·
QEB
Anesthesiology
·
265d
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3
Anesthesiology
3