510k
Database
Specialties
Anesthesiology
541
Cardiovascular
1680
Chemistry
364
Dental
1336
Ear, Nose, Throat
245
Gastroenterology & Urology
971
General & Plastic Surgery
2191
General Hospital
2046
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2916
Pathology
52
Physical Medicine
515
Radiology
2435
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
408
LLZ
System, Image Processing,...
386
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
303
IYN
System, Imaging, Pulsed Doppler,...
296
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
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Customed, Inc.
Medical Device Manufacturer
·
US , Carolina Puerto Rico
Customed, Inc. - FDA 510(k) Cleared Devices
36 submissions
·
26 cleared
·
Since 1990
36
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Customed, Inc.
Ear, Nose, Throat
✕
1
devices
1-1 of 1
Filters
Cleared
Apr 26, 1993
SURGICAL TRAY (STERILE)
K925022
·
LRD
Ear, Nose, Throat
·
214d
Filters
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All
36
General Hospital
14
General & Plastic Surgery
10
Gastroenterology & Urology
4
Obstetrics & Gynecology
4
Anesthesiology
2
Ear, Nose, Throat
1
Chemistry
1