10 results
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18ms
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Sources: EU EUDAMED, US FDA
(I) LV AND (II) HV SERIES CANNULA
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GC Initial™
FDA UDI
Gc America Inc.·15400556705800·GC Initial™ LF Opaqus Dentin ODC4, 20g
GC Initial™
FDA UDI
Gc America Inc.·J0228710431·GC Initial™ LF Opaqus Dentin ODC4, 20g
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014
SOF-FLEX DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK UROLOGICAL, INC.·Product code FAD·October 8, 2010
ROD, FIXATION, INTRAMEDULLARY
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·June 26, 2015
ALARIS
FDA Adverse Event
Malfunction
·CAREFUSION 303, INC.·Product code FRN·June 24, 2020
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIRE-CUF , Product Code/List Number/Item Code 65P030; c) PAED, TRACHEOSTOMY TUBE 3.5mm AIRE-CUF , Product Code/List Number/Item Code 65P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM AIRE-CUF , Product Code/List Number/Item Code 65P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM AIRE-CUF , Product Code/List Number/Item Code 65P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM AIRE-CUF , Product Code/List Number/Item Code 65P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM AIRE-CUF , Product Code/List Number/Item Code 65P055;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024