16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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