510k
Database
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Anesthesiology
553
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1736
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387
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1407
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258
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997
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2244
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2105
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127
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105
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8
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477
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988
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452
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286
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3087
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52
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517
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2517
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156
Categories
LZA
Polymer Patient Examination Glove
423
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System, Image Processing,...
402
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Powered Laser Surgical Instrument
366
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Mask, Surgical
361
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Electrosurgical, Cutting &...
313
IYN
System, Imaging, Pulsed Doppler,...
306
HRS
Plate, Fixation, Bone
300
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
238
MAX
Intervertebral Fusion Device...
235
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Cardioline S.P.A
Medical Device Manufacturer
·
US , Cavareno , TN
Cardioline S.P.A - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2015
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardioline S.P.A
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
May 15, 2023
HD+12, HD+15
K220526
·
DRG
Cardiovascular
·
445d
Cleared
Nov 02, 2016
CARDIOLINE touchECG
K160746
·
DPS
Cardiovascular
·
229d
Cleared
Aug 12, 2016
ECG100+, ECG200+
K160840
·
DPS
Cardiovascular
·
137d
Cleared
Aug 27, 2015
CARDIOLINE HD+
K150289
·
DRG
Cardiovascular
·
203d
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Cardiovascular
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