16 results · 22ms · Sources: EU EUDAMED, US FDA

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Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MAXIM VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304205727·

MAXIM® VI KNEE SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00887868225796·

LEUCADIA PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MULTI-USE COMPRESSION SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

PS FEMORAL COMPONENT CLOSED BOX LGE RIGHT 74 MM CEMENTED

FDA Adverse Event
Malfunction ·BIOMET SPAIN, S.L.·Product code JWH·June 3, 2020

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 17, 2015

SUNBEAM

FDA Adverse Event
Injury ·SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS·Product code IRT·May 30, 2013

QUATTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·September 23, 2014

OCTRODE PERCUTANEOUS LEAD

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 23, 2011

PERF CON TIB BRG LRG 22X60

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

NON-POROUS PERF TIB TRAY-LGE

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

PERF ANAT TIBIAL STEM 120X14X5

FDA Adverse Event
Injury ·BIOMET SPAIN, S.L.·Product code KRR·August 13, 2020

EVOLUT R TRANSCATHETER AORTIC VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 5, 2021

ACTIVA

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 13, 2017

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