19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EYE PAD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VARIAX
FDA UDI
Stryker GmbH·07613327125887·Core Tray Reduction Instr Drawer Clip
3M™ ESPE™
FDA UDI
3M COMPANY·30605861030756·3M™ ESPE™ Gold Anodized Crown Refills, First Mo...
VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR WITHOUT VISORS, TIES AND EARLOOPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASCEND
FDA 510(k)
FDA Class 2
·Neurology
HEARTMATE II LEFT VENTIRCULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·June 19, 2014
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·February 2, 2013
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·December 20, 2010
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Injury
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·August 16, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·December 1, 2021
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 11, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 4, 2023
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·March 20, 2024
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·September 9, 2022
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·July 8, 2022
BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·February 1, 2022
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020