12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Aspira Universal Adapter
FDA UDI
Bard Access Systems, Inc.·00801741045066·Aspira Universal Adapter
Aspira®
FDA UDI
Merit Medical Systems, Inc.·00884450620632·
Aspira®
FDA UDI
Merit Medical Systems, Inc.·00884450394977·
IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR
FDA 510(k)
FDA Class 2
·Radiology
Nihon Kohden NKV-550 Series Ventilator System
FDA 510(k)
FDA Class 2
·Anesthesiology
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 1, 2013
CAPSURE Z NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
VIVA QUAD S
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·August 8, 2014
ENCOREANYWHERE
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 17, 2016
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