510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1703
Chemistry
375
Dental
1351
Ear, Nose, Throat
250
Gastroenterology & Urology
980
General & Plastic Surgery
2215
General Hospital
2065
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
439
Ophthalmic
282
Orthopedic
2991
Pathology
52
Physical Medicine
515
Radiology
2473
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
415
LLZ
System, Image Processing,...
398
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
302
HRS
Plate, Fixation, Bone
285
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
225
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Agendia, Inc.
Medical Device Manufacturer
·
US , Irvina , CA
Agendia, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Agendia, Inc.
Pathology
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 08, 2022
MammaPrint FFPE NGS Kit
K210973
·
NYI
Pathology
·
526d
Cleared
Nov 05, 2020
MammaPrint
K201902
·
NYI
Pathology
·
120d
Filters
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2
Pathology
2