11 results
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26ms
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Sources: EU EUDAMED, US FDA
CHOLINESTERASE TEST KIT
FDA 510(k)
FDA Class 1
·Clinical Toxicology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150591·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 200mm
Freedom Primary PCK
FDA 510(k)
FDA Class 2
·Orthopedic
POWERED MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FNL·January 11, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 2, 2010
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code LWP·July 3, 2014
STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC
FDA Adverse Event
Malfunction
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code OVE·October 4, 2019
STARDRIVE SCREWDRIVER SHAFT T8 SELF-RETAINING/QC
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KWQ·April 27, 2020
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