8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
PHENOBARBITAL REAGENT TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACUMED
FDA UDI
Acumed LLC·10806378091155·1.3mm Non-threaded Guide Wire, 150mm
ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART
FDA 510(k)
FDA Class 2
·Radiology
SYNCHRO HP PLATFORM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
M2A 38MM MODULAR HEAD STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 23, 2012
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 16, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022