23 results · 21ms · Sources: EU EUDAMED, 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