10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
FDA 510(k)
FDA Class 2
·Immunology
Polystar Selection EDITION
FDA UDI
Merz Dental GmbH·D7091981354·anteriors; shade D2; mould CM6
PILLOWS- SINGLE PATIENT USE
FDA 510(k)
FDA Class 1
·General Hospital
074 Zenith Flex System
FDA 510(k)
FDA Class 2
·Cardiovascular
TELESCOPE "TRUEVIEW II", 4 MM, 30°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·May 23, 2023
TELESCOPE "TRUEVIEW II", 4 MM, 70°, AUTOCLAVABLE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code HRX·April 24, 2023
ENRHYTHM
FDA Adverse Event
Death
·IPG MFG SWITZERLAND·Product code NVZ·February 27, 2013
INTEGRATED APD SET W/CASSETTE3 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 8, 2011
EEA 31MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GDW·July 24, 2014
Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 8, 2017