510k
Database
Specialties
Anesthesiology
545
Cardiovascular
1693
Chemistry
370
Dental
1347
Ear, Nose, Throat
250
Gastroenterology & Urology
979
General & Plastic Surgery
2206
General Hospital
2052
Hematology
126
Immunology
100
Medical Genetics
8
Microbiology
473
Neurology
980
Obstetrics & Gynecology
438
Ophthalmic
280
Orthopedic
2977
Pathology
52
Physical Medicine
515
Radiology
2465
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
397
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
358
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
299
HRS
Plate, Fixation, Bone
283
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
232
MAX
Intervertebral Fusion Device...
224
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Custom Medical, Inc.
Medical Device Manufacturer
·
US , Mchenry , IL
Custom Medical, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1983
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Custom Medical, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 12, 1983
RED COLOR-TINTED TUBING
K832758
·
FPK
General Hospital
·
24d
Cleared
May 09, 1983
CUSTOM IV SET
K830182
·
FPA
General Hospital
·
111d
Filters
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3
General Hospital
2
Anesthesiology
1