510k
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Anesthesiology
508
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1581
Chemistry
355
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1270
Ear, Nose, Throat
233
Gastroenterology & Urology
920
General & Plastic Surgery
2106
General Hospital
1834
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126
Immunology
91
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8
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449
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923
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419
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265
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2677
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49
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506
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2289
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154
Categories
LZA
Polymer Patient Examination Glove
377
LLZ
System, Image Processing,...
356
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
HRS
Plate, Fixation, Bone
260
FXX
Mask, Surgical
258
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Phenox, Ltd.
Medical Device Manufacturer
·
IE , Galway
Phenox, Ltd. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2022
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Phenox, Ltd.
Neurology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 15, 2026
Esperance pHLO Aspiration System
K251357
·
NRY
Neurology
·
260d
Cleared
Nov 12, 2024
pNOVUS 21 Microcatheter
K242420
·
DQO
Neurology
·
89d
Cleared
Nov 28, 2022
pNOVUS 21 Microcatheter
K221279
·
DQO
Neurology
·
209d
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3
Neurology
3