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