18 results · 25ms · Sources: EU EUDAMED, US FDA

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HealthOST

FDA 510(k)
FDA Class 2 ·Radiology

AVOSET INFUSION PUMP ROW

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

AVOSET INFUSION PUMP ROW

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

JOSTRA DUAL STAGE VENOUS RETURN CANNULAE

FDA 510(k)
FDA Class 2 ·Cardiovascular

KOSTEC MEDICAL GRADE LDC MONITORS

FDA 510(k)
FDA Class 2 ·Radiology

SYRINGE 10ML LL S/C 200

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 9, 2021

AVOSET INFUSION PUMP ROW

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 25, 2025

BD SYRINGE LUER-LOK TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 1, 2021

AVOSET INFUSION PUMP ROW

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·June 22, 2025

AVOSET INFUSION PUMP ROW

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·December 23, 2025

AVOSET INFUSION PUMP ROW

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026

AVOSET INFUSION PUMP ROW

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·January 5, 2026

AVOSET INFUSION PUMP ROW

FDA Adverse Event
Malfunction ·EITAN MEDICAL LTD.·Product code FRN·April 29, 2026

MBT CEM KEEL TIB TRAY SZ3

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·October 27, 2008

ASR ACETABULAR CUPS 58

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

ENSPIRE

FDA Adverse Event
Injury ·SPINE VIEW INC.·Product code HRX·July 9, 2013

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021