15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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