510k
Database
Specialties
Anesthesiology
130
Cardiovascular
565
Chemistry
162
Dental
309
Ear, Nose, Throat
68
Gastroenterology & Urology
286
General & Plastic Surgery
511
General Hospital
369
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
60
Ophthalmic
49
Orthopedic
1285
Pathology
18
Physical Medicine
85
Radiology
866
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
99
MBI
Fastener, Fixation,...
84
NHA
Abutment, Implant, Dental,...
83
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
82
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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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) cleared devices by 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