7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
MODEL WC-115 MOBILE BASSINET
FDA 510(k)
FDA Class 2
·General Hospital
COPAL DIGITAL SPHYGMOMAMOMETER UA-550
FDA 510(k)
FDA Class 2
·Cardiovascular
KC 100 M
FDA 510(k)
FDA Class 2
·Radiology
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 19, 2014
HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code LFL·October 18, 2010
OT PING METER
FDA Adverse Event
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 22, 2012
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