12 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)
FDA 510(k)
FDA Class 2
·Neurology
EDL ONE-STAGE PROTHROMBIN TIME REAGENT
FDA 510(k)
FDA Class 2
·Hematology
DIGITAL TRANSTELEPHONIC ECG MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ASR ACETABULAR CUPS 62
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·January 4, 2013
ZEPHYR XL DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010
VERSACARE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·May 20, 2014
SERIES A PAT W/WR STD 31 1 PEG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 28, 2021
E1 VNGD CR TIB BRG 87/91X10
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 28, 2021
BIOMET CC CRUCIATE TRAY 87MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·October 28, 2021
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014