9 results
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21ms
·
Sources: EU EUDAMED, US FDA
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
NuVasive CoRoent Thoracolumbar System
FDA 510(k)
FDA Class 2
·Orthopedic
KONICA MINOLTA PULSOX-300, 300I
FDA 510(k)
FDA Class 2
·Cardiovascular
NCIRCLE TIPLESS STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·August 6, 2018
STRUT, LARGE, 08MM
FDA Adverse Event
Malfunction
·ZIMMER SPINE·Product code NKB·April 4, 2014
PROPLEGE CORONARY SINUS CATHETER
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DWF·November 30, 2012
PUMP MMT-712WWB PRDGM INSULIN BL EN PR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·September 27, 2010
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024