11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
REFLOTRON CREATINE KINASE TEST TABS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Graft Preparation Board
FDA UDI
Biomet Orthopedics, LLC·00887868511080·
GRAFT PREPARATION BOARD
FDA UDI
Biomet Orthopedics, LLC·00880304467200·
MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE
FDA 510(k)
FDA Class 2
·Neurology
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458
FDA 510(k)
FDA Class 3
·Cardiovascular
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·May 13, 2019
EON MINI IMPLANTABLE PULSE GENERATOR
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC.·Product code CBK·November 29, 2012
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024