18 results · 21ms · Sources: EU EUDAMED, US FDA

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Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

IMMUNOCARD C. DIFFICILE GDH

FDA 510(k)
FDA Class 1 ·Microbiology

POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE

FDA 510(k)
FDA Class 1 ·General Hospital

BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code LHI·January 25, 2022

BD SMARTSITE 13MM CLOSED VIAL ACCESS DEVICE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·January 25, 2022

BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·January 25, 2022

BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code LHI·February 24, 2022

BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code LHI·April 16, 2022

BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code LHI·July 29, 2022

BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·July 29, 2022

BD SMARTSITE¿ VIALSHIELD CLOSED VIAL ACCESS DEVICE, 13 MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code LHI·February 23, 2022

ETHICON LIGAMAX 5MM

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY·Product code GDO·October 24, 2008

LIFEVEST WCD 3100 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 8, 2011

TOTAL ASR FEM IMP SIZE 51

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 8, 2013

OSV II

FDA Adverse Event
Injury ·INTEGRA NEUROSCICENCS IMPLANTS SA·Product code JXG·June 9, 2021

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025