510k
Database
Specialties
Anesthesiology
540
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1663
Chemistry
362
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1334
Ear, Nose, Throat
244
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963
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2184
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2043
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126
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97
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8
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466
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963
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433
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274
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2875
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52
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515
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2430
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155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
383
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Mask, Surgical
358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
302
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
219
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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) Regulatory Record - Healthy.Io, Ltd.
Chemistry
✕
4
devices
1-4 of 4
Filters
Cleared
Sep 08, 2023
Minuteful-kidney test
K222921
·
JIR
Chemistry
·
347d
Cleared
CT
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