510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
316
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1295
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
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...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Warantec Co., Ltd.
Medical Device Manufacturer
·
US , Deer Field , IL
Warantec Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2009
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Warantec Co., Ltd.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 02, 2023
Warantec Custom Abutment
K221972
·
NHA
Dental
·
454d
Cleared
May 12, 2023
IU Implant System Abutment
K221969
·
NHA
Dental
·
311d
Cleared
Jun 18, 2018
IU Implant System
K172345
·
DZE
Dental
·
320d
Cleared
Mar 27, 2009
ONEPLANT DENTAL IMPLANT SYSTEM
K081748
·
DZE
Dental
·
281d
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4
Dental
4