510k
Database
Specialties
Anesthesiology
522
Cardiovascular
1608
Chemistry
356
Dental
1300
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2131
General Hospital
1973
Hematology
126
Immunology
91
Medical Genetics
8
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449
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940
Obstetrics & Gynecology
426
Ophthalmic
271
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2696
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
402
LLZ
System, Image Processing,...
367
GEX
Powered Laser Surgical Instrument
350
FXX
Mask, Surgical
346
GEI
Electrosurgical, Cutting &...
294
QIH
Automated Radiological Image...
273
IYN
System, Imaging, Pulsed Doppler,...
264
HRS
Plate, Fixation, Bone
262
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Diagnosys, LLC
Medical Device Manufacturer
·
US , Lowell , MA
Diagnosys, LLC - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2022
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Diagnosys, LLC
Ophthalmic
✕
1
devices
1-1 of 1
Filters
Cleared
Nov 22, 2022
E3 and Profile
K221471
·
GWE
Ophthalmic
·
186d
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Ophthalmic
1