510k
Database
Specialties
Anesthesiology
550
Cardiovascular
1723
Chemistry
386
Dental
1390
Ear, Nose, Throat
256
Gastroenterology & Urology
990
General & Plastic Surgery
2232
General Hospital
2093
Hematology
127
Immunology
104
Medical Genetics
8
Microbiology
474
Neurology
985
Obstetrics & Gynecology
443
Ophthalmic
286
Orthopedic
3064
Pathology
52
Physical Medicine
515
Radiology
2505
Toxicology
156
Categories
LZA
Polymer Patient Examination Glove
418
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
365
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
310
IYN
System, Imaging, Pulsed Doppler,...
305
HRS
Plate, Fixation, Bone
298
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
234
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Ipax, Inc.
Medical Device Manufacturer
·
US , CO
Ipax, Inc. - FDA 510(k) Cleared Devices
18 submissions
·
18 cleared
·
Since 1984
18
Total
18
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ipax, Inc.
General Hospital
✕
4
devices
1-4 of 4
Filters
Cleared
May 04, 2021
ProntoPump Sterile Tube Set
K200893
·
LHI
General Hospital
·
396d
Cleared
Apr 23, 1987
TIMLEINE(TM) VENIPUNCTURE SYSTEM
K870770
·
KMK
General Hospital
·
56d
Cleared
Jun 04, 1986
TIMELINE VENIPUNCTURE SYSTEM
K860609
·
FPA
General Hospital
·
105d
Cleared
Jun 04, 1986
TIMELINE VENIPUNCTURE SYSTEM
K861182
·
FPA
General Hospital
·
65d
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18
Ophthalmic
10
General & Plastic Surgery
4
General Hospital
4