510k
Database
Specialties
Anesthesiology
138
Cardiovascular
573
Chemistry
165
Dental
321
Ear, Nose, Throat
68
Gastroenterology & Urology
293
General & Plastic Surgery
530
General Hospital
379
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
64
Ophthalmic
51
Orthopedic
1298
Pathology
18
Physical Medicine
88
Radiology
880
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Leone S.P.A.
Medical Device Manufacturer
·
US , Irvine , CA
Leone S.P.A. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2006
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Leone S.P.A.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 19, 2025
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
K242944
·
OAT
Dental
·
267d
Cleared
Feb 22, 2008
LEONE ORTHODONTIC MINI IMPLANT
K071490
·
OAT
Dental
·
268d
Cleared
Apr 19, 2007
LEONE MONOIMPLANT FOR O-RING OVERDENTURE
K070483
·
DZE
Dental
·
58d
Cleared
Feb 27, 2006
LEONE IMPLANT SYSTEM
K050586
·
DZE
Dental
·
357d
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4
Dental
4