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

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SR-1 Skin Treatment System

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

Wet-Field® Eraser®

FDA UDI
Beaver-Visitec International, Inc.·30886158012024·23 GA Fine Tip

BD BBL™ Levine EMB Agar

FDA UDI
BECTON, DICKINSON AND COMPANY·10382902212680·BD BBL™ Levine EMB Agar

ECLIPSE, HELIOS OPTION

FDA 510(k)
FDA Class 2 ·Radiology

WANDY DISPERSVIE ELECTRODE

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

BD BBL¿ LEVINE EMB AGAR

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSI·August 3, 2021

HT50 VENTILATOR

FDA Adverse Event
Injury ·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·November 3, 2014

MESH - COMPOSIX KUGEL

FDA Adverse Event
Injury ·DAVOL INC·Product code FTL·August 17, 2011

UPHOLD VAGINAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013

BD BBL¿ LEVINE EMB AGAR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·August 25, 2021

BD BBL¿ LEVINE EMB AGAR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·November 2, 2021

BD BBL¿ LEVINE EMB AGAR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·August 6, 2021

BD BBL¿ LEVINE EMB AGAR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSI·February 14, 2022

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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