12 results
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26ms
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Sources: EU EUDAMED, US FDA
LCA 2000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GC Initial™
FDA UDI
Gc America Inc.·15400556705718·GC Initial™ LF Opaqus Dentin ODA3.5, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228710341·GC Initial™ LF Opaqus Dentin ODA3.5, 20g
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704292459·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771012177·K-Wires, Double diamond, .054-inch (1.4mm) diam...
NA
FDA UDI
KEY SURGICAL, INC.·10849771048821·K-Wires, Double diamond, .054-inch (1.4mm) diam...
HI-MID CURCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014
SOLETRA
FDA Adverse Event
Injury
·MEDTRONIC EUROPE SARL·Product code MHY·October 12, 2010
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ILJ·December 12, 2012
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024