510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1723
Chemistry
386
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1390
Ear, Nose, Throat
256
Gastroenterology & Urology
990
General & Plastic Surgery
2232
General Hospital
2093
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127
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104
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8
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474
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985
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443
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286
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3064
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52
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515
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2505
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156
Categories
LZA
Polymer Patient Examination Glove
418
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
365
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
305
HRS
Plate, Fixation, Bone
298
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
234
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P-Cure, Ltd.
Medical Device Manufacturer
·
IL , Netanya, Hasharon
P-Cure, Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2010
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - P-Cure, Ltd.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
May 12, 2025
P-Cure Proton Therapy System (PPTS)
K242418
·
LHN
Radiology
·
270d
Cleared
Mar 20, 2023
P-Cure Proton Beam Therapy System
K221996
·
LHN
Radiology
·
257d
Cleared
Aug 08, 2016
P-ARTIS
K160611
·
JAK
Radiology
·
158d
Cleared
Mar 05, 2010
P-ART, MODEL 001
K092424
·
IYE
Radiology
·
210d
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4
Radiology
4