17 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TOP DISPOSABLE INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
CoRoent
FDA UDI
Nuvasive, Inc.·00887517376220·CoRoent Contoured Trial, 5L
ReLine
FDA UDI
Nuvasive, Inc.·00195377020727·RELINE-C Ti Rod, 3.5x25mm Straight
Endodontic Hand Instruments
FDA UDI
TULSA DENTAL PRODUCTS LLC·D71668410251·Ready•Steel K-FILE 010 25MM
Precept
FDA UDI
Nuvasive, Inc.·00887517370129·PRECEPT Rod, 25mm
BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
FDA 510(k)
FDA Class 2
·Physical Medicine
ARTIMES BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Zimmer, Inc.·00889024193451·
NA
FDA UDI
Zimmer, Inc.·00889024193437·
NA
FDA UDI
Zimmer, Inc.·00889024193482·
NA
FDA UDI
Zimmer, Inc.·00889024193468·
NA
FDA UDI
Zimmer, Inc.·00889024193475·
NA
FDA UDI
Zimmer, Inc.·00889024193444·
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·May 14, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 20, 2012
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 12, 2015
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