Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Results for “TRUEtome™”
Name, manufacturer or identifier
Search
Manufacturer
(optional)
Filters
Filters
Registry
EUDAMED
24
FDA 510(k) incl. De Novo
1
FDA PMA
GUDID
24
Country / market
European Union (all)
24
United States
25
More countries (1)
Netherlands
24
Risk class
Class I
Class IIa
Class IIb
24
Class III
Class II (US)
1
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
Verified only
Category (EMDN)
Browse by category
Apply filters
25 devices found
·
sorted by relevance
Key
Clear all
Device
Device · Manufacturer · Authorizations
Verified
Verified
Status
Status
Regime
Regime
Registry
Registry
Class
Class
TRUEtome™
Boston Scientific
·
,
United States
Group of variants
CE/MDR
GUDID
on market
Active
Regimes:
CE MDR
Registry:
EUDAMED
GUDID
Class
Class:
IIb
Truetome
Boston Scientific
·
,
United States
FDA 510(k)
K122203
Active
Cleared 17 Aug 2012
Active
Regimes:
510(k)
Registry:
510(k)
Class
Class:
II
Previous
Next
Showing 21-25 of 25