510k
Database
Specialties
Anesthesiology
509
Cardiovascular
1583
Chemistry
355
Dental
1271
Ear, Nose, Throat
233
Gastroenterology & Urology
920
General & Plastic Surgery
2107
General Hospital
1841
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
925
Obstetrics & Gynecology
420
Ophthalmic
265
Orthopedic
2677
Pathology
50
Physical Medicine
506
Radiology
2289
Toxicology
154
Categories
LZA
Polymer Patient Examination Glove
378
LLZ
System, Image Processing,...
356
GEX
Powered Laser Surgical Instrument
347
GEI
Electrosurgical, Cutting &...
292
QIH
Automated Radiological Image...
272
IYN
System, Imaging, Pulsed Doppler,...
263
FXX
Mask, Surgical
262
HRS
Plate, Fixation, Bone
260
OLO
Orthopedic Stereotaxic Instrument
217
NHA
Abutment, Implant, Dental,...
204
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Koru Medical Systems, Inc.
Medical Device Manufacturer
·
US , Mahwah , NJ
Koru Medical Systems, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2026
Official Website
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Koru Medical Systems, Inc.
General Hospital
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 28, 2026
FreedomEdge Infusion System
K252015
·
FRN
General Hospital
·
215d
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1
General Hospital
1