18 results · 19ms · Sources: EU EUDAMED, US FDA

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TRANSESOPHAGEAL ECHO TRANSDUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

MODEL JY PACEMAKER LEAD - VARIOUS

FDA 510(k)
FDA Class 3 ·Cardiovascular

FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·April 20, 2015

AXIUM

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code HCG·March 27, 2023

PIPELINE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 27, 2023

SCREW, FIXATION, BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HWC·April 20, 2015

PLATE, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code HRS·April 21, 2015

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 19, 2014

LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·October 22, 2010

R SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORP.·Product code MKJ·November 15, 2012

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·April 4, 2024

MICRA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code DYB·February 20, 2025

MICRA

FDA Adverse Event
Death ·MEDTRONIC IRELAND·Product code PNJ·February 20, 2025

MICRA

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code PNJ·February 20, 2025

dS Breast 7ch 3.0T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 4, 2024

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026