510k
Database
Specialties
Anesthesiology
522
Cardiovascular
1610
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
927
General & Plastic Surgery
2131
General Hospital
1978
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
940
Obstetrics & Gynecology
426
Ophthalmic
271
Orthopedic
2697
Pathology
52
Physical Medicine
514
Radiology
2319
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
367
GEX
Powered Laser Surgical Instrument
350
FXX
Mask, Surgical
347
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
Browse all 339 categories →
Search
Reports
Glossary
About
Home
Ascensia Diabetes Care U.S., Inc.
Medical Device Manufacturer
·
US , Mishawaka , IN
Ascensia Diabetes Care U.S., Inc. - FDA 510(k) Cleared Devices
7 submissions
·
7 cleared
·
Since 2016
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ascensia Diabetes Care U.S., Inc.
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
May 14, 2025
MICROLET®NEXT 2 Lancing Device
K250813
·
QRL
General & Plastic Surgery
·
58d
Cleared
Aug 15, 2024
MICROLET®NEXT Lancet
K241810
·
QRK
General & Plastic Surgery
·
55d
Cleared
CT
Jun 03, 2022
MICROLET NEXT lancing device, MICROLET Lancet
K220633
·
QRL
General & Plastic Surgery
·
91d
Filters
Filter by Specialty
All
7
Chemistry
4
General & Plastic Surgery
3