3,341 results
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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