17 results
·
36ms
·
Sources: EU EUDAMED, US FDA
W2 WRIST CPM UNIT
FDA 510(k)
FDA Class 1
·Physical Medicine
LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
CUSA Excel+
FDA 510(k)
FDA Unclassified
·Unknown
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 30, 2026
MEDTRONIC
FDA Adverse Event
Injury
·MEDTRONIC·Product code DQY·December 29, 2010
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·February 8, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 22, 2014
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
NEXIVA DIFFUSICS
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 16, 2026
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