8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123113·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 125mm
SURX RF SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MY01 Continuous Compartmental Pressure Monitor
FDA 510(k)
FDA Unclassified
·Unknown
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 17, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Injury
·Product code KDJ·December 13, 2010
JRNY BCS II
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·July 8, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024