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