8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CROSS PIN SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DURACON CRUCIFORM TIBIAL BASEPLATE
FDA 510(k)
FDA Class 2
·Orthopedic
BOUFFANT CAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 6, 2013
CONFIENT
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 4, 2011
LINEAR 7.5 FR. 34CC IAB
FDA Adverse Event
Death
·DATASCOPE CORP.·Product code DSP·July 2, 2014
Ureteral dilator, REF RBD014
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·April 10, 2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024