13 results · 25ms · Sources: EU EUDAMED, US FDA

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ARTICULATED CHIN IMPLANT

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

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·00636257073438·PROTECT PATELLA TRACKING BRACE, LT, XL

Iconix

FDA UDI
RIVERPOINT MEDICAL, LLC·00812444029857·Iconix 1 TT, 1.4mm Anchor with 1 Strand 1.2mm X...

Iconix

FDA UDI
RIVERPOINT MEDICAL, LLC·00812444029840·Iconix 1, 1.4mm Anchor with 1 Strand #1 XBraid ...

Iconix

FDA UDI
RIVERPOINT MEDICAL, LLC·00812444029758·Iconix HA+ 1, 1.4mm Anchor with 1 Strand #2 XBr...

Iconix

FDA UDI
RIVERPOINT MEDICAL, LLC·00812444029734·Iconix HA+ 1 TT, 1.4mm Anchor with 1 Strand 1.2...

INSTRUMENTS FOR ONE TIME USE - DISPOSABLE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

SBV2, MULTICHARGER MODEL MC10V2

FDA 510(k)
FDA Class 2 ·Neurology

DUROM ACETABULAR COMPONENT 48/42 H

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWA·May 27, 2014

UNKNOWN DEPUY TIBIAL INSERT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 29, 2010

FINELINE II

FDA Adverse Event
Malfunction ·CPI - DEL CARIBE·Product code NVN·January 11, 2013

VITEK® 2 AST-GP75 TEST KIT

FDA Adverse Event
Malfunction ·BIOMERIEUX, INC·Product code LON·February 12, 2018

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