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

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EXACTECH GPS

FDA 510(k)
FDA Class 2 ·Neurology

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704508895·

BD LUER-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 9, 2024

DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 3

FDA Adverse Event
Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·May 3, 2016

DIACAP ULTRA DIALYSIS FLUID FILTER

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

RESOLUTION II CLIP

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

DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 4

FDA Adverse Event
Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·May 3, 2016

DURAGEN PLUS DURAL REGENERATION MATRIX 3X3 5 PAC

FDA Adverse Event
Injury ·INTEGRA LIFESCIENCES CORPORATION·Product code GXQ·May 3, 2016

CELL-DYN RUBY ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·October 8, 2014

CARELINK

FDA Adverse Event
Malfunction ·TRIVIRIX MINNEAPOLIS·Product code NVZ·June 8, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

FOGARTY

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES PR·Product code MJN·March 24, 2025

OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021