3,341 results · 39ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Edora 8, Evity 8, Enitra 8, Enticos 8 HF-T QPs,Edora 8, Evity 8, Enitra 8, Enticos 8 HF-Ts and PSW 1601.U Pacemaker/ICD/

Puritan

FDA UDI
Puritan Medical Products·00609576140037·Sterile Foam Tipped Applicators

SPF

Basic UDI-DI
EU MDR · Eu Md Class 1 ·Amity Limited·6 devices

TEPA1DPFMSKCC

FDA UDI
UTAK LABORATORIES, INC.·B800TEPA1DPFMSKCC0·TEPA1DPFMSKCC

BUSULFAN LEVEL 2

FDA UDI
UTAK LABORATORIES, INC.·B800BUS2DPFDU0·BUSULFAN LEVEL 2

CLOFARABINE PLUS LEVEL 2

FDA UDI
UTAK LABORATORIES, INC.·B800CLOF2DPFMSKCC0·CLOFARABINE PLUS LEVEL 2

CLOFARABINE PLUS LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800CLOF1DPFMSKCC0·CLOFARABINE PLUS LEVEL 1

BUSULFAN LEVEL 3

FDA UDI
UTAK LABORATORIES, INC.·B800BUS3DPFDU0·BUSULFAN LEVEL 3

MPA LEVEL 2

FDA UDI
UTAK LABORATORIES, INC.·B800MPA2DPFFUMC0·MPA LEVEL 2

MPA LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800MPA1DPFFUMC0·MPA LEVEL 1

BUSULFAN LEVEL 1

FDA UDI
UTAK LABORATORIES, INC.·B800BUS1DPFDU0·BUSULFAN LEVEL 1

TEPA2DPFMSKCC

FDA UDI
UTAK LABORATORIES, INC.·B800TEPA2DPFMSKCC0·TEPA2DPFMSKCC

CLOFARABINE PLUS LEVEL 3

FDA UDI
UTAK LABORATORIES, INC.·B800CLOF3DPFMSKCC0·CLOFARABINE PLUS LEVEL 3

TEPA3DPFMSKCC

FDA UDI
UTAK LABORATORIES, INC.·B800TEPA3DPFMSKCC0·TEPA3DPFMSKCC

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Sentus ProMRI OTW QP S-75, S-85, S-95, L-75, L-95, S-75/49, S-85/49, S-95/49, L-75/49, L-85/49 and Sentus ProMRI OTW QP

BUSULFAN LEVEL 4

FDA UDI
UTAK LABORATORIES, INC.·B800BUS4VDPFDU0·BUSULFAN LEVEL 4

Medline International France

Authorized representative
🇫🇷 France·3 Manufacturers

DiaCart 720g OP/F/C

Basic UDI-DI
EU MDR · Eu Md Class 2b ·Serumwerk Bernburg AG·7 devices

DiaCart 720 g OP/F

Basic UDI-DI
EU MDD · Eu Md Class 2b ·Serumwerk Bernburg Vertriebs GmbH·1 device