11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
FDA 510(k)
FDA Class 2
·Immunology
ZMR®
FDA UDI
Zimmer, Inc.·00889024157255·
ZMR®
FDA UDI
Zimmer, Inc.·00889024157248·
TIGR SURGICAL MESH , MODEL WK-6
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BTL-899
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PAGEWRITER
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DRG·February 28, 2013
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·February 15, 2011
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·June 11, 2019
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017