510k
Database
Specialties
Anesthesiology
132
Cardiovascular
568
Chemistry
162
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
513
General Hospital
370
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1288
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18
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85
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866
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Saliwell , Ltd.
Medical Device Manufacturer
·
IL , Harutzim
Saliwell , Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2017
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Saliwell , Ltd.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 13, 2023
SaliPen
K232063
·
QTT
Dental
·
155d
Cleared
Aug 30, 2022
SaliPen
K220618
·
QTT
Dental
·
180d
Cleared
Nov 06, 2018
SaliPen
K180838
·
LTF
Dental
·
221d
Cleared
Feb 17, 2017
GenNarino
K160799
·
LTF
Dental
·
331d
Filters
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4
Dental
4