510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
165
Dental
318
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
524
General Hospital
375
Hematology
67
Immunology
57
Medical Genetics
0
Microbiology
234
Neurology
172
Obstetrics & Gynecology
62
Ophthalmic
51
Orthopedic
1295
Pathology
18
Physical Medicine
87
Radiology
871
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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Healthy.Io, Ltd.
Medical Device Manufacturer
·
IL , Tel Aviv
Healthy.Io, Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2018
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Healthy.Io, Ltd.
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 08, 2023
Minuteful-kidney test
K222921
·
JIR
Chemistry
·
347d
Cleared
Jul 06, 2022
Minuteful - kidney test
K210069
·
JIR
Chemistry
·
541d
Cleared
Jul 26, 2019
ACR LAB Urine Analysis Test System
K182384
·
JFY
Chemistry
·
329d
Cleared
Jul 18, 2018
DIP/U.S. Urine Analysis Test System
K173327
·
JIL
Chemistry
·
271d
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4
Chemistry
4