8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
RIM-HAEMOPHILUS 1 & 2
FDA 510(k)
FDA Class 1
·Microbiology
VISULAS green
FDA 510(k)
FDA Class 2
·Ophthalmic
BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P
FDA 510(k)
FDA Class 3
·Cardiovascular
ARIS TRANS-OBTURATOR
FDA Adverse Event
Injury
·COLOPLAST A/S·Product code FTL·February 7, 2014
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 14, 2012
ACRYSOF IQ TORIC
FDA Adverse Event
Malfunction
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·September 3, 2010
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
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024