10 results
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18ms
·
Sources: EU EUDAMED, US FDA
PLEURAL DRAINAGE SYSTEM #PDS-4300
FDA 510(k)
FDA Class 2
·General Hospital
ERA® Implant Abutment Std. Ang. Base, 1.6mm Cuff (BF)
FDA UDI
STERNGOLD DENTAL LLC·00841549103056·Implant retained overdentures are an establishe...
SUNTANNING DEVICE (SEPAR. FROM K812225)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SafeAir Smoke Evacuator compact
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·March 21, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INCORPORATED·Product code GJS·August 20, 2010
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018