510k
Database
Specialties
Anesthesiology
450
Cardiovascular
1367
Chemistry
334
Dental
1058
Ear, Nose, Throat
194
Gastroenterology & Urology
808
General & Plastic Surgery
1780
General Hospital
1214
Hematology
121
Immunology
84
Medical Genetics
7
Microbiology
420
Neurology
767
Obstetrics & Gynecology
336
Ophthalmic
211
Orthopedic
2426
Pathology
44
Physical Medicine
410
Radiology
1977
Toxicology
143
Categories
GEX
Powered Laser Surgical Instrument
290
LLZ
System, Image Processing,...
281
GEI
Electrosurgical, Cutting &...
253
QIH
Automated Radiological Image...
251
IYN
System, Imaging, Pulsed Doppler,...
241
HRS
Plate, Fixation, Bone
236
LZA
Polymer Patient Examination Glove
206
OLO
Orthopedic Stereotaxic Instrument
198
NHA
Abutment, Implant, Dental,...
187
MAX
Intervertebral Fusion Device...
168
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Tyto Care , Ltd.
Medical Device Manufacturer
·
IL , Netanya
Tyto Care , Ltd. - FDA 510(k) Cleared Devices
9 submissions
·
8 cleared
·
Since 2016
Official Website
9
Total
8
Cleared
1
Denied
FDA 510(k) Regulatory Record - Tyto Care , Ltd.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Mar 12, 2026
Tyto Stethoscope (G3)
K252089
·
DQD
Cardiovascular
·
253d
Cleared
Dec 17, 2018
Tyto Stethoscope (OTC)
K181612
·
DQD
Cardiovascular
·
181d
Cleared
Oct 19, 2016
Tyto Stethoscope
K160401
·
DQD
Cardiovascular
·
250d
Filters
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9
Anesthesiology
4
Cardiovascular
3
Ear, Nose, Throat
1
General Hospital
1