9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER
FDA 510(k)
FDA Class 1
·Anesthesiology
TEXTURED POWDER FREE NITRILE EXAM GLOVES (PEACH)
FDA 510(k)
FDA Class 1
·General Hospital
Male Latex Condoms
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYMBIQ SINGLE CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 20, 2014
CAPSURE Z NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010
COYOTE¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·December 10, 2012
Peri GYN, part number PSS2193(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
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