510k
Database
Specialties
Anesthesiology
531
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1642
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359
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1314
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242
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954
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2166
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2031
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126
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97
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8
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462
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951
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433
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274
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2819
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52
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515
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2400
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
379
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Mask, Surgical
357
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
283
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
208
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Palliare , Ltd.
Medical Device Manufacturer
·
IE , Galway
Palliare , Ltd. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2020
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Palliare , Ltd.
Obstetrics & Gynecology
✕
4
devices
1-4 of 4
Filters
Cleared
May 02, 2024
EVA15 insufflator
K232902
·
HIF
Obstetrics & Gynecology
·
227d
Cleared
Jan 27, 2023
EVA15 insufflator
K222901
·
HIF
Obstetrics & Gynecology
·
126d
Cleared
Oct 21, 2020
EVA15
K202799
·
HIF
Obstetrics & Gynecology
·
28d
Cleared
Jul 23, 2020
EVA 15 Insufflator
K193520
·
HIF
Obstetrics & Gynecology
·
217d
Filters
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6
Obstetrics & Gynecology
4
Gastroenterology & Urology
2