510k
Database
Specialties
Anesthesiology
464
Cardiovascular
1400
Chemistry
334
Dental
1094
Ear, Nose, Throat
201
Gastroenterology & Urology
827
General & Plastic Surgery
1839
General Hospital
1313
Hematology
124
Immunology
86
Medical Genetics
7
Microbiology
420
Neurology
787
Obstetrics & Gynecology
351
Ophthalmic
222
Orthopedic
2449
Pathology
47
Physical Medicine
418
Radiology
2024
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
300
LLZ
System, Image Processing,...
297
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
254
IYN
System, Imaging, Pulsed Doppler,...
244
HRS
Plate, Fixation, Bone
242
LZA
Polymer Patient Examination Glove
230
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
170
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A2j, Inc.
Medical Device Manufacturer
·
US , Houston , TX
A2j, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 1988
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - A2j, Inc.
Radiology
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 08, 1993
AZ 92
K931974
·
IWE
Radiology
·
169d
Cleared
Jan 04, 1991
A2J TELEMETER
K904127
·
IWE
Radiology
·
128d
Cleared
Apr 27, 1988
A2J MZ 45 LASER LIGHT FOR POSITIONING
K881591
·
IWX
Radiology
·
14d
Cleared
Apr 22, 1988
A2J MZ 44 B TYPE
K880981
·
IWE
Radiology
·
45d
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4
Radiology
4