16 results · 21ms · Sources: EU EUDAMED, US FDA

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Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate

FDA 510(k)
FDA Class 1 ·General Hospital

MobileLink Acetabular Cup System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575185436·UHMWPE Inserts -X-LINKed; Standard (Neutral)

MobileLink Acetabular Cup System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575187201·UHMWPE Inserts -X-LINKed; Standard (Neutral)

MobileLink Acetabular Cup System

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575187195·UHMWPE Inserts -X-LINKed; Standard (Neutral)

EBONY PTA .035 PERIPHERAL DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

FLORASEAL, MODEL FS350D

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·July 22, 2022

NEXIVA DIFFUSICS

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·March 30, 2026

LINER: MPACT FLAT PE HC LINER Ø36/F

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·June 12, 2019

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 18, 2014

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 21, 2013

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 28, 2011

BELIFU

FDA Adverse Event
Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T

FDA Enforcement
Class II ·Terminated·Integra LifeSciences Corp.·April 24, 2019

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025