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