10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
16GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDL
FDA 510(k)
FDA Class 2
·Anesthesiology
LONG NAIL KIT R2.0, TI, LEFT GAMMA3 ?11X400MM X 13
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·December 4, 2012
HUNTLEIGH AIR-O-PAD AOP1 ALTERNATING PRESS-MATTRES
FDA 510(k)
FDA Class 2
·General Hospital
RADIATION BEAM DATA ACQUISTIOIN SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
SMALL PERIPHERAL CUTTING BALLOON®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·June 25, 2014
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 4, 2010
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 3, 2013
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·June 8, 2016
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020