17 results
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35ms
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Sources: EU EUDAMED, US FDA
SANA HEALTH, INC.
FDA registration
SANA HEALTH, INC.·1 product·🇺🇸 United States
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·June 30, 2025
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·June 30, 2025
Aysam Ortopedi ve Tıbbi Aletler Sanayi ve Ticaret Limited Şirketi
Manufacturer
🇹🇷 Türkiye·14122 Basic UDI-DIs·14863 Devices·HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), HTCert (Health Technology Certification Ltd), UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.
MYNX CONTROL VENOUS
FDA Adverse Event
Malfunction
·CARDINAL HEALTH SANTA HEALTH·Product code MGB·February 24, 2025
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
FDA Recall
Terminated
·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·June 9, 2016
Fresenius 2008T Hemodialysis Machine: Part Number Description 190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS; 190713 2008T HEMODIAL YSIS SYS., with CDX; 190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG; 190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX; 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD System With CDX, CAN
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·March 12, 2020
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B2
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001B2
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item Number: 720001B0
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001B0
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F2
FDA Recall
Open, Classified
·Getinge Usa Sales Inc·Product code FQO·October 3, 2024
Caretechion GmbH
Authorized representative
🇩🇪 Germany·158 Manufacturers·1463 Devices
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices