510k
Database
Specialties
Anesthesiology
527
Cardiovascular
1634
Chemistry
356
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
946
General & Plastic Surgery
2157
General Hospital
2020
Hematology
126
Immunology
92
Medical Genetics
8
Microbiology
459
Neurology
948
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2795
Pathology
52
Physical Medicine
515
Radiology
2368
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
276
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Sim&Cure
Medical Device Manufacturer
·
FR , Grabels
Sim&Cure - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2019
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sim&Cure
Neurology
✕
5
devices
1-5 of 5
Filters
Cleared
Dec 23, 2025
Sim&Size
K253122
·
PZO
Neurology
·
89d
Cleared
Dec 14, 2024
Sim&Size
K242124
·
PZO
Neurology
·
148d
Cleared
Jan 27, 2023
Sim&Size
K222664
·
PZO
Neurology
·
147d
Cleared
Jan 27, 2022
Sim&Size
K212373
·
PZO
Neurology
·
181d
Cleared
Dec 31, 2020
Sim&Size
K202322
·
PZO
Neurology
·
136d
Filters
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6
Neurology
5
Cardiovascular
1