510k
Database
Specialties
Anesthesiology
130
Cardiovascular
565
Chemistry
161
Dental
309
Ear, Nose, Throat
67
Gastroenterology & Urology
286
General & Plastic Surgery
511
General Hospital
368
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
163
Obstetrics & Gynecology
60
Ophthalmic
49
Orthopedic
1285
Pathology
18
Physical Medicine
85
Radiology
865
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
133
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
98
MBI
Fastener, Fixation,...
84
LNH
System, Nuclear Magnetic...
83
NHA
Abutment, Implant, Dental,...
83
MAX
Intervertebral Fusion Device...
82
NKB
Thoracolumbosacral Pedicle Screw...
80
JAK
System, X-ray, Tomography, Computed
79
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Carlsmed, Inc.
Medical Device Manufacturer
·
US , La Jolla , CA
Carlsmed, Inc. - FDA 510(k) Cleared Devices
19 submissions
·
19 cleared
·
Since 2020
19
Total
19
Cleared
0
Denied
FDA 510(k) cleared devices by Carlsmed, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Dec 20, 2024
aprevo® Digital Planning
K242599
·
LLZ
Radiology
·
112d
Cleared
Nov 03, 2023
aprevo® Digital Segmentation
K231955
·
QIH
Radiology
·
123d
Cleared
Dec 30, 2022
aprevo® Digital Workflow
K222195
·
LLZ
Radiology
·
161d
Filters
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19
Orthopedic
16
Radiology
3