14 results · 22ms · Sources: EU EUDAMED, US FDA

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Luggie Super

FDA 510(k)
FDA Class 2 ·Physical Medicine

FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Ophthalmic

NB3D BONE VOID FILLER

FDA 510(k)
FDA Class 2 ·Orthopedic

PASSEO-18 5/200/90

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

PASSEO-18 6/200/90

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·September 28, 2021

SEDLINE KIT

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

PASSEO-18 2.5/170/130

FDA Adverse Event
Malfunction ·BIOTRONIK AG, BUELACH, SWITZERLAND·Product code LIT·January 20, 2021

SEDLINE KIT

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code MWI·January 8, 2017

SEDLINE KIT

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017

TI MATRIX LOCKING CAP

FDA Adverse Event
Injury ·SYNHES (USA) BRANDYWINE·Product code NKB·June 7, 2013

TARGIS SYSTEM

FDA Adverse Event
Malfunction ·UROLOGIX, INC.·Product code MEQ·July 7, 2011

PYXIS ANESTHESIA SYSTEM 3500

FDA Adverse Event
Malfunction ·CARDINAL HEALTH - PYXIS PRODUCTS·Product code BRY·September 5, 2008

BD INSYTE¿ AUTOGUARD¿

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·December 20, 2018

ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023