18 results · 43ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

P150048

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 23, 2024

P150048

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 26, 2025

CARTIVA

FDA Adverse Event
Injury ·CARTIVA, INC·Product code PNW·July 21, 2020

COBAS® EGFR MUTATION TEST V2 P150044

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·April 1, 2026

COBAS® EGFR MUTATION TEST V2 P150044

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·April 15, 2026

COBAS® EGFR MUTATION TEST V2 P150044

FDA Adverse Event
Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OWD·March 27, 2025

X-STOP® INTERSPINOUS SPACER

FDA Adverse Event
Injury ·MDT KYPHON SUNNYVALE MFG·Product code NQO·June 6, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 7, 2014

TISSUE HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 11, 2020

CARTIVA DEVICE 10MM T20-0329

FDA Adverse Event
Injury ·CARTIVA, INC·Product code PNW·April 23, 2021

SEE. H10.

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·December 1, 2020

REPLACEMENT HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 13, 2020

REPLACEMENT HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·May 29, 2019

SEE H11

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·February 27, 2025

EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code LWR·September 27, 2024

HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·February 3, 2020

HEARTWARE VENTRICULAR ASSIST SYSTEM - WAIST PACK

FDA Adverse Event
Malfunction ·HEARTWARE, INC.·Product code DSQ·March 31, 2020