13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
MODEL 3587A RESUME II LEAD
FDA 510(k)
FDA Class 2
·Neurology
MEGA PLUS MIS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665582423·MIS Cannulated Screw, Ø5.5 x 40mm, Ø5.5mm Rod
PROTH-AURO 22
FDA 510(k)
FDA Class 2
·Dental
RESPIRONICS BIPAP REMOTE CONTROL UNIT
FDA 510(k)
FDA Class 2
·Anesthesiology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·June 4, 2014
ZIMMER SKIN GRAFT MESHER
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code FZW·January 10, 2013
ACTIVA PC
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·November 5, 2010
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 14, 2020
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 14, 2020
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·November 11, 2020
SMOOTH ROUND MOD. PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR MEDICAL SYSTEM B.V.·Product code FTR·February 25, 2025
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021