Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Results for “EnSite™”
Name, manufacturer or identifier
Search
Manufacturer
(optional)
Filters
Filters
Registry
EUDAMED
200
FDA 510(k)
48
FDA PMA
GUDID
243
Country / market
European Union (all)
29
United States
291
More countries (1)
Belgium
29
Risk class
Class I
9
Class IIa
Class IIb
20
Class III
Class II (US)
276
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)
Not classified (FDA)
Verified
Validated only
Category (EMDN)
Browse by category
Apply filters
305 devices found
·
sorted by relevance
Key
Clear all
Device · Manufacturer · Authorizations
Verified
Status
Regime
Registry
Class
EnSite™ ENSITE-CL-01
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
II
EnSite™ ENSITE-WS-01
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
II
EnSite™ ENSITE-DWS-04
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
II
EnSite™ ENSITE-FF-01
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
II
EnSite™ ENSITE-OTAC-03
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
CE/MDR
GUDID
on market
Active
CE MDR
EUDAMED
GUDID
II
EnSite™ ENSITE-SW-1.1.2
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
CE/MDD
GUDID
on market
Active
CE MDD
EUDAMED
GUDID
II
EnSite™
UDI-DI 05415067033529
Abbott Medical
·
,
Ireland
Class I
CE/MDR
Active
CE MDR
EUDAMED
I
6 variants
EnSite™
75-04490-001
EnSite™
ENSITE-ECGOUT-I-01
EnSite™
ENSITE-ECGRO-I-01
EnSite™
ENSITE-SRFLNK-I-01
See all variants of this device
EnSite™
UDI-DI 05415067036551
Abbott Medical
·
,
Ireland
Class IIb
CE/MDR
Active
CE MDR
EUDAMED
IIb
5 variants
EnSite™
ENSITE-D-CFLF-01
EnSite™
ENSITE-SYSTEM-1.1
EnSite™
ENSITE-TF-01
See all variants of this device
EnSite™
Abbott Medical Costa Rica Ltda.
·
,
Costa Rica
Class I
CE/MDR
Active
CE MDR
EUDAMED
I
EnSite™ Velocity™
Abbott Medical
·
,
Ireland
Class I
CE/MDR
Active
CE MDR
EUDAMED
I
EnSite™ ENSITE-VM-CBL
St. Jude Medical, Inc.
·
,
United States
(FDA 510(k) applicant)
Class II
GUDID
on market
None
GUDID
II
EnSite™ X EP System
Abbott Medical
·
,
Ireland
Class II
FDA 510(k)
K262006
Active
Cleared 15 Jul 2026
Active
510(k)
510(k)
II
7 variants
EnSite™ X EP System
K261729
See all variants of this device
Previous
Next
Showing 181-200 of 305