510k
Database
Specialties
Anesthesiology
479
Cardiovascular
1456
Chemistry
338
Dental
1153
Ear, Nose, Throat
214
Gastroenterology & Urology
845
General & Plastic Surgery
1906
General Hospital
1448
Hematology
125
Immunology
90
Medical Genetics
8
Microbiology
427
Neurology
821
Obstetrics & Gynecology
363
Ophthalmic
239
Orthopedic
2504
Pathology
49
Physical Medicine
439
Radiology
2073
Toxicology
146
Categories
GEX
Powered Laser Surgical Instrument
310
LLZ
System, Image Processing,...
306
LZA
Polymer Patient Examination Glove
280
GEI
Electrosurgical, Cutting &...
261
QIH
Automated Radiological Image...
256
HRS
Plate, Fixation, Bone
247
IYN
System, Imaging, Pulsed Doppler,...
247
OLO
Orthopedic Stereotaxic Instrument
206
NHA
Abutment, Implant, Dental,...
197
MAX
Intervertebral Fusion Device...
174
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Irex Corp.
Medical Device Manufacturer
·
US , Mchenry , IL
Irex Corp. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1977
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Irex Corp.
Cardiovascular
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 31, 1985
COLOR DOPPLER 880
K843643
·
DXK
Cardiovascular
·
136d
Cleared
Aug 12, 1981
DOPPLER ULTRASOUND BLOOD FLOWMETER
K811246
·
DPW
Cardiovascular
·
99d
Cleared
Dec 27, 1979
IREX CARDIOPLAN
K792525
·
DQK
Cardiovascular
·
21d
Cleared
Aug 04, 1977
SYSTEM II
K771372
·
DSF
Cardiovascular
·
10d
Filters
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10
Radiology
6
Cardiovascular
4