11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AUTOLET
FDA 510(k)
FDA Class 2
·Hematology
PULSE
FDA UDI
Nuvasive, Inc.·00195377057037·PULSE LessRay Tablet Charging Station
ACUMED
FDA UDI
Acumed LLC·10806378051760·Hand Plates & External Fixation Platter
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135516·
DC ZIRKON
FDA 510(k)
FDA Class 2
·Dental
VOCALIS GEL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 11, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·October 23, 2012
PERSONAL CYCLER MACHINE 100 VOLTS
FDA Adverse Event
Death
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·August 16, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021