510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1709
Chemistry
380
Dental
1355
Ear, Nose, Throat
252
Gastroenterology & Urology
982
General & Plastic Surgery
2215
General Hospital
2079
Hematology
126
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100
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8
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474
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980
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441
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282
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3023
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52
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515
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2486
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155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
399
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
290
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
231
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Leana Orders, Inc.
Medical Device Manufacturer
·
US , Staten Island , NY
Leana Orders, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Leana Orders, Inc.
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Jul 20, 2021
Grivamax Family of Lasers, Models 272 and 148
K211192
·
OAP
General & Plastic Surgery
·
90d
Cleared
Aug 22, 2017
Grivamax Hair Growth System
K171895
·
OAP
General & Plastic Surgery
·
57d
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2
General & Plastic Surgery
2