5,927 results
·
51ms
·
Sources: EU EUDAMED, US FDA
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS COCHLEAR IMPLANT SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·Combi 40+ Cochlear Implant System
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·COCHLEAR NUCLEUS C1512 IMPLANT SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·Nucleus N22 Cochlear Implant Systems
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·Nucleus 24 Cochlear Implant System
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·MAESTRO System Software 9.0
Zimmerman/Norymberski, 17-Ketogenic Steroids
FDA classification
FDA Class 1
·Zimmerman/Norymberski, 17-Ketogenic Steroids
Tube, Smoke Removal, Endoscopic
FDA classification
FDA Class 1
·Tube, Smoke Removal, Endoscopic
BioButton v3 (BBN-r, different batch)
FDA UDI
BIOINTELLISENSE, INC.·00850005949299·Note: 00850005949299 (Model# BIOST06040) is equ...
1434-IVDD-403/2020
Certificate
IVDD Annex IV (excluding sections 4, 6)·TÜRKLAB TIBBİ MLZ. SAN. VE TİC. AŞ.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·1 Basic UDI-DI
BioButton v3 (BBN-r)
FDA UDI
BIOINTELLISENSE, INC.·00850005949183·The BioButton™ is a remote monitoring wearable ...
24 0237 QR/NB
Certificate
MDR QMS·VINAMET CZ s.r.o.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
MVZ Labor Krone GbR
System producer
🇩🇪 Germany
Conformal Brachytherapy Source
FDA classification
FDA Class 2
·Conformal Brachytherapy Source
Galdent CZ s.r.o.
Authorized representative
🇨🇿 Czechia·1 Manufacturer
2021-MDD/QS-022
Certificate
MDD Annex II (excluding section 4)·OR-CZ spol. s r.o.·3EC International a.s.·1 Basic UDI-DI