8 results
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17ms
·
Sources: EU EUDAMED, US FDA
REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION
FDA 510(k)
FDA Class 1
·Anesthesiology
MINK LUNG
FDA 510(k)
FDA Class 1
·Hematology
STERILE EQUIPMENT COVERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SERVO-I
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·June 25, 2014
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·January 7, 2011
DEPTH GAUGE FOR 3.5MM CORTEX SCREWS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HTJ·March 27, 2023
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024