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
53 devices
51-53 of 53
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
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All89 Cardiovascular 53 Gastroenterology & Urology 16 General Hospital 7 Orthopedic 7 General & Plastic Surgery 3 Ophthalmic 1 Radiology 1 Pathology 1