10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DRG TITANIUM BONE PLATE
FDA 510(k)
FDA Class 2
·Dental
Epredia
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693236614·Glyo-Fixx is formulated for use as a histologic...
INTRACRANIAL PRESSURE MONITORING
FDA 510(k)
FDA Class 2
·Neurology
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
FDA 510(k)
FDA Class 2
·Immunology
SUPRAMID BLACK 4/0 (1.5) 45CM DS19
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAR·September 12, 2019
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 6, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·August 8, 2014
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 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