17 results · 36ms · Sources: EU EUDAMED, US FDA

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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