12 results · 26ms · Sources: EU EUDAMED, US FDA

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ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

FDA 510(k)
FDA Class 2 ·Orthopedic

Sklar®

FDA UDI
SKLAR CORPORATION·10649111085543·LOVELACE HEMO FCP SERR 6 1/4"

Accent 1000 Keyguard 8 Location

FDA UDI
PRENTKE ROMICH COMPANY·00858526006378·Keyguards are made from thick, clear polycarbon...

VIEWPOINT 6

FDA 510(k)
FDA Class 2 ·Radiology

BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)

FDA 510(k)
FDA Class 2 ·Dental

REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 16, 2021

REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 6, 2019

CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCE

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DYB·October 10, 2014

INSTINCT ENDOSCOPIC HEMOCLIP

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC.·Product code MND·June 6, 2013

PRECISION®

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 23, 2011

CANNULATED CRUCIFORM SCREWDRIVER

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·May 13, 2022

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