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

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NEON SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

COMPREHENSIVE SHOULDER SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304554030·

SCREW,FIXATION,BONE

FDA Adverse Event
Injury ·SYNTHES MONUMENT·Product code HWC·June 9, 2017

DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY

FDA 510(k)
FDA Class 2 ·Dental

GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE

FDA 510(k)
FDA Class 2 ·Dental

REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·October 31, 2023

HARMONIC ACE

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·May 6, 2013

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

PINNACLE MTL INS NEUT36IDX50OD

FDA Adverse Event
Injury ·DEPUY INTL., LTD.·Product code KWA·May 20, 2011

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code HWC·June 2, 2015

BD 10ML SYRINGE LUER-LOK¿ TIP

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 6, 2022

REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·March 3, 2023

SCREW, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES SELZACH·Product code HWC·June 3, 2015

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

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