510k
Database
Specialties
Anesthesiology
130
Cardiovascular
562
Chemistry
161
Dental
309
Ear, Nose, Throat
67
Gastroenterology & Urology
286
General & Plastic Surgery
510
General Hospital
368
Hematology
67
Immunology
56
Medical Genetics
0
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232
Neurology
163
Obstetrics & Gynecology
60
Ophthalmic
49
Orthopedic
1285
Pathology
18
Physical Medicine
84
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
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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Efofex, Inc.
Medical Device Manufacturer
·
US , Rogers , AR
Efofex, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Efofex, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 19, 2026
Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)
K253398
·
FXX
General Hospital
·
142d
Cleared
Mar 27, 2023
Disposable Surgical Face Mask
K223823
·
FXX
General Hospital
·
96d
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2
General Hospital
2