13 results
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33ms
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Sources: EU EUDAMED, US FDA
MINERALS MODIFIED MED. BASE & SOD. GLUT.
FDA 510(k)
FDA Class 1
·Microbiology
ERA® 0° DO Small Post Attachment SS
FDA UDI
STERNGOLD DENTAL LLC·00841549101878·This DO Post attachment contains 1 female, 2 bl...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK114201·DD tempMED are pre-colored dental milling blank...
MM-87 MOTOR-DRIVE MANIPULATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Aequalis Flex Revive Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
LEGEND FOOTED ATTACHMENT
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·May 15, 2014
ATTAIN STARFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012
CROSSER RECANALIZATION CATHETER
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·May 22, 2015
OSS 7CM SEGMENTAL FEMORAL RT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 9, 2020
OSS CEMENTED IM STEM 13X150
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·September 9, 2020
SMR CONNECTOR SMALL STD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·March 31, 2022
REFOBACIN BONE CEMENT R 1X40G
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code MBB·October 12, 2020
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021