510k
Database
Specialties
Anesthesiology
332
Cardiovascular
1061
Chemistry
269
Dental
805
Ear, Nose, Throat
148
Gastroenterology & Urology
622
General & Plastic Surgery
1321
General Hospital
752
Hematology
98
Immunology
72
Medical Genetics
1
Microbiology
365
Neurology
574
Obstetrics & Gynecology
244
Ophthalmic
155
Orthopedic
2050
Pathology
40
Physical Medicine
309
Radiology
1581
Toxicology
132
Categories
GEX
Powered Laser Surgical Instrument
228
HRS
Plate, Fixation, Bone
210
IYN
System, Imaging, Pulsed Doppler,...
208
QIH
Automated Radiological Image...
205
LLZ
System, Image Processing,...
199
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
156
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
135
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American Edwards Laboratories
Medical Device Manufacturer
·
US , Walker , MI
American Edwards Laboratories - FDA 510(k) Cleared Devices
89 submissions
·
88 cleared
·
Since 1980
89
Total
88
Cleared
0
Denied
FDA 510(k) Regulatory Record - American Edwards Laboratories
Radiology
✕
1
devices
1-1 of 1
Filters
Cleared
Jul 28, 1981
CARDIAC 1000 TM
K811094
·
JAA
Radiology
·
98d
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89
Cardiovascular
53
Gastroenterology & Urology
16
General Hospital
7
Orthopedic
7
General & Plastic Surgery
3
Ophthalmic
1
Radiology
1
Pathology
1