10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
IMMUNOGLOBULIN A NEPHEL. ASSAY
FDA 510(k)
FDA Class 2
·Immunology
ANKLE HINDFOOT NAILING SYSTEM
FDA UDI
ORTHOFIX SRL·18053340347396·ANKLE HINDFOOT REVISION NAIL TI L250MM D12MM ST...
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
UTS Stem
FDA 510(k)
FDA Class 2
·Orthopedic
START-X TIP EMS INSERT 2
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code ELC·May 31, 2023
START-X TIP EMS INSERT 2
FDA Adverse Event
Malfunction
·MAILLEFER INSTRUMENTS HOLDING SARL·Product code ELC·August 8, 2023
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·October 4, 2012
NOVA MAX PLUS GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS·Product code NBW·April 1, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·July 22, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021