510k
Database
Specialties
Anesthesiology
540
Cardiovascular
1666
Chemistry
362
Dental
1334
Ear, Nose, Throat
245
Gastroenterology & Urology
963
General & Plastic Surgery
2186
General Hospital
2043
Hematology
126
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97
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8
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466
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965
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433
Ophthalmic
274
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2886
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52
Physical Medicine
515
Radiology
2431
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
384
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
353
GEI
Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
270
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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Cruxell Corp.
Medical Device Manufacturer
·
KR , Daejeon
Cruxell Corp. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cruxell Corp.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 29, 2021
CRUXVIEW
K211317
·
MUH
Radiology
·
90d
Cleared
Feb 12, 2019
Cruxcan (CRX-1000)
K183637
·
MUH
Radiology
·
48d
Filters
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2
Radiology
2