13 results · 23ms · Sources: EU EUDAMED, US FDA

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SLIM E30 II CO2 LASER

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

EMIT 2000 GENTAMICIN PLUS ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

XYLOS VESSEL GUARD

FDA 510(k)
FDA Class 2 ·Cardiovascular

CONTOUR

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012

BD INTIMA II¿ IV CATHETER PRN ADAPTER

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·March 9, 2023

OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016

BD INTIMA II¿ IV CATHETER PRN ADAPTER

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·September 19, 2022

UNKNOWN ZIMMER KNEE

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·May 9, 2013

MAXILIFT

FDA Adverse Event
Malfunction ·ARJO MED AB LTD.·Product code FSA·April 1, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·September 4, 2025

Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

ACCOLADE DR EL MRI (Model L331)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025