8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
APTT-ES
FDA 510(k)
FDA Class 2
·Hematology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471122376·K-WIRE - SINGLE TROCAR THREADED 1.6mm DIA x 230mm
SHIMADZU RADIOGRAPJHIC STAND BR-100
FDA 510(k)
FDA Class 2
·Radiology
EXCEL MODEL XLT-TWO HOLMIUM:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·January 14, 2013
KENTROX RV-S 65
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·December 6, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·July 15, 2014
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
FDA Enforcement
Class II
·Ongoing·Biointellisense Inc.·August 21, 2024