14 results · 27ms · Sources: EU EUDAMED, US FDA

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Geon (S2) Nasal Aspirator

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AxSOS 3 Ti Locking Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134

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

BD ULTRA-FINE¿ PEN NEEDLE

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FMI·January 8, 2024

ACRYSOF

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·November 21, 2008

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·September 11, 2011

PUMP IN STYLE ADVANCED BREAST PUMP TO TOTE

FDA Adverse Event
Malfunction ·MEDELA, INC.·Product code HGX·July 18, 2013

IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·April 21, 2022

IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·February 7, 2023

ALINITY I RUBELLA IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 26, 2025

ALINITY I RUBELLA IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·November 7, 2025

ALINITY I RUBELLA IGG REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code LFX·February 13, 2026

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

Model Number L111, ESSENTIO DR SL MRI Pacemaker

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