Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Results for “”
Name, manufacturer or identifier
Search
Manufacturer
(optional)
Filters
1 active
Filters
1 active
Registry
EUDAMED
FDA 510(k)
89
FDA PMA
1
GUDID
Country / market
United States
90
Risk class
Class I
7
Class IIa
Class IIb
Class III
2
Class II (US)
76
More classes (11)
Class A
Class B
Class C
Class D
IVD General
IVD Annex II List A
IVD Annex II List B
IVD for self-testing
Active implantable (AIMDD)
Unclassified (FDA)
3
Not classified (FDA)
Verified
Validated only
Category (EMDN)
Browse by category
Apply filters
Reset
90 devices found
·
sorted by relevance
Key
Manufacturer: American Edwards Laboratories
×
Clear all
Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
Diaflex Occlusion Balloon Catheter
American Edwards Laboratories
·
,
FDA registration: United States
Class II
FDA 510(k)
K850790
Active
Cleared 25 Mar 1985
Active
510(k)
510(k)
II
Amer. Edwards Lab Diaflex Ureteral Dila
American Edwards Laboratories
·
,
FDA registration: United States
Class II
FDA 510(k)
K842639
Active
Cleared 2 Oct 1984
Active
510(k)
510(k)
II
Cardiac 1000 Tm
American Edwards Laboratories
·
,
FDA registration: United States
Class II
FDA 510(k)
K811094
Active
Cleared 28 Jul 1981
Active
510(k)
510(k)
II
Right Ventricular Ejection Fraction-
American Edwards Laboratories
·
,
FDA registration: United States
Class II
FDA 510(k)
K842105
Active
Cleared 15 Jan 1985
Active
510(k)
510(k)
II
Paper Chart Recorder
American Edwards Laboratories
·
,
FDA registration: United States
Class I
FDA 510(k)
K811254
Active
Cleared 10 Jul 1981
Active
510(k)
510(k)
I
Amer. Edwards Lab Flexiscope
American Edwards Laboratories
·
,
FDA registration: United States
Class I
FDA 510(k)
K842410
Active
Cleared 5 Nov 1984
Active
510(k)
510(k)
I
Thermodilution Cardiac Output Computer, Mod. Com-2
American Edwards Laboratories
·
,
FDA registration: United States
Class II
FDA 510(k)
K872529
Active
Cleared 15 Sep 1987
Active
510(k)
510(k)
II
Modification Of Carpentier-Edwards Bioprosthesis
American Edwards Laboratories
·
,
FDA registration: United States
Class I
FDA 510(k)
K864155
Active
Cleared 20 Nov 1986
Active
510(k)
510(k)
I
Nephrostomy Guidewire Sheath
American Edwards Laboratories
·
,
FDA registration: United States
Unclassified
FDA 510(k)
K845047
Active
Cleared 15 Jan 1985
Active
510(k)
510(k)
—
Garren Gastric Bubble
American Edwards Laboratories
·
,
FDA registration: United States
Class III
FDA PMA
P840025
Active
Approved 18 Dec 1985
Active
PMA
PMA
III
Previous
Next
Showing 81-90 of 90