510k
Database
Specialties
Anesthesiology
202
Cardiovascular
732
Chemistry
187
Dental
459
Ear, Nose, Throat
88
Gastroenterology & Urology
389
General & Plastic Surgery
762
General Hospital
468
Hematology
77
Immunology
62
Medical Genetics
1
Microbiology
274
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294
Obstetrics & Gynecology
113
Ophthalmic
76
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1472
Pathology
26
Physical Medicine
151
Radiology
1079
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93
Categories
IYN
System, Imaging, Pulsed Doppler,...
165
HRS
Plate, Fixation, Bone
150
OLO
Orthopedic Stereotaxic Instrument
129
LLZ
System, Image Processing,...
123
GEX
Powered Laser Surgical Instrument
123
QIH
Automated Radiological Image...
109
GEI
Electrosurgical, Cutting &...
104
NHA
Abutment, Implant, Dental,...
104
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Nitiloop , Ltd.
Medical Device Manufacturer
·
IL , Herzliya
Nitiloop , Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2015
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Nitiloop , Ltd.
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 02, 2020
NovaCross CTO Microcatheter
K193322
·
DQY
Cardiovascular
·
122d
Cleared
Oct 18, 2017
NovaCross Microcatheter
K172297
·
DQY
Cardiovascular
·
79d
Cleared
Mar 11, 2016
NovaCross Microcatheter
K160389
·
DQY
Cardiovascular
·
29d
Cleared
May 04, 2015
NovaCross Microcatheter
K143608
·
DQY
Cardiovascular
·
136d
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4
Cardiovascular
4