21 results · 23ms · 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.

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

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

50CM IMPLANT LEAD KIT, SLIM TIP

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·December 10, 2018

50CM IMPLANT LEAD KIT, SLIM TIP

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·December 10, 2018

50CM IMPLANT LEAD KIT, SLIM TIP

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·December 10, 2018

50CM IMPLANT LEAD KIT, SLIM TIP

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·August 31, 2018

PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·August 5, 2019

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

COLLEAGUE PRE P1.7

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

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 30, 2013

TISSUE HEART VALVE

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

KIT IMPLANTABLE SLIM TIP LEAD, 50CM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·August 19, 2019

KIT IMPLANTABLE SLIM TIP LEAD, 50CM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code PMP·August 19, 2019

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