510k
Database
Specialties
Anesthesiology
6718
Cardiovascular
15426
Chemistry
11482
Dental
10396
Ear, Nose, Throat
2880
Gastroenterology & Urology
8131
General & Plastic Surgery
14591
General Hospital
12868
Hematology
2715
Immunology
3213
Medical Genetics
20
Microbiology
6037
Neurology
5141
Obstetrics & Gynecology
3486
Ophthalmic
3202
Orthopedic
17081
Pathology
900
Physical Medicine
3322
Radiology
13291
Toxicology
2720
Categories
Powered Laser Surgical Instrument
GEX
2537
System, Image Processing, Radiological
LLZ
2135
Electrosurgical, Cutting &...
GEI
2005
Implant, Endosseous, Root-form
DZE
1374
Plate, Fixation, Bone
HRS
1304
Laparoscope, General & Plastic Surgery
GCJ
1167
System, Imaging, Pulsed Doppler,...
IYN
1156
Polymer Patient Examination Glove
LZA
1153
System, Nuclear Magnetic Resonance...
LNH
1021
Screw, Fixation, Bone
HWC
1017
Browse all 339 categories →
Manufacturers
Search
Reports
Glossary
About
Search FDA 510(k) devices
510k Database
Manufacturers
IE
Abbott Ireland
Share
Medical Device Manufacturer
·
IE , Lisnamuck
Abbott Ireland - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2025
Recent clearances:
Glucose2
,
Calcium2
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Ireland
Chemistry
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 24, 2025
Glucose2
K252357
·
CFR
Chemistry
·
87d
Cleared
Feb 10, 2025
Calcium2
K244042
·
CJY
Chemistry
·
42d
Filters
Filter by Specialty
All
2
Chemistry
2