7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
BIOTIS TCBS AGAR
FDA 510(k)
FDA Class 1
·Microbiology
CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
RELIA S
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code NVZ·June 10, 2014
CAPSURE EPI
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·October 8, 2010
PROXIMATE PPH PROCEDURE SET
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 10, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021