15 results · 34ms · Sources: EU EUDAMED, US FDA

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SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ISOZYME - ID CPK MARKER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Actreen Hi-Lite Cath, Actreen Hi-Lite Set

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 6, 2024

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·April 9, 2014

COMPLETE SE ILIAC

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NIO·December 20, 2012

VISISTAT SKIN STAPLER 35W

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code GDT·September 30, 2010

Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

FDA Enforcement
Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020