23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KOWA DR-1a
FDA 510(k)
FDA Class 2
·Ophthalmic
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319705513·Frazier Ferguson Suction Tube 8Fr. (2.6mm), w/ ...
FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDART 620
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
READY VIEW
FDA 510(k)
FDA Class 2
·Radiology
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
CARDINAL HEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024
CARDINALHEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024
CARDINALHEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024
CARDINALHEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024
CARDINALHEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008
CLINITRON RITEHITE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code INX·June 13, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
CARDINALHEALTH
FDA Adverse Event
Malfunction
·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024
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 Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·April 29, 2020
Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713, 2008T Hemodialysis System with CDX Part Number 190766, 2008T Hemodialysis System with biBag The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
FDA Recall
Terminated
·Fresenius Medical Care Holdings, Inc.·January 19, 2011