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1954
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1550
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1432
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Search FDA 510(k) devices
510k Database
Manufacturers
US
American Edwards Laboratories
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Medical Device Manufacturer
·
US , Walker , MI
American Edwards Laboratories - FDA 510(k) Cleared Devices
89 submissions
·
88 cleared
·
Since 1980
View 89 510(k) Devices ↓
89
Total
88
Cleared
0
Denied
53
devices
51-53 of 53
Filters
1
2
3
Cleared
Jan 13, 1981
ADVANCEMED HOLTER RECORDERS
K803224
·
DSH
Cardiovascular
·
25d
Cleared
Jan 13, 1981
ADVANCEMED EXAMINER
K803225
·
DSF
Cardiovascular
·
25d
Cleared
Nov 26, 1980
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670
·
DXK
Cardiovascular
·
30d
1
2
3
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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