13 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VYGON EXTENSION TUBES & CONNECTORS
FDA 510(k)
FDA Class 2
·Cardiovascular
Burr
FDA UDI
KATENA PRODUCTS, INC.·00841668119990·Algerbrush II, Complete W/1mm Burr
Bioplate®
FDA UDI
Bioplate, Inc.·M3848131400·BioMesh® 2MC - 132 x 134 mm
Bioplate®
FDA UDI
Bioplate, Inc.·M384813140CP0·BioMesh® 2MC - 132 x 134 mm
Bioplate®
FDA UDI
Bioplate, Inc.·M384813140US0·BioMesh® 2MC - 132 x 134 mm
VARI-LASE WIREFIBER LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
FDA 510(k)
FDA Class 2
·Dental
POLISHED FINNED TIB TRAY 79MM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRO·March 28, 2019
FREESTYLE
FDA Adverse Event
Malfunction
·Product code LFR·May 15, 2014
CAPSUREFIX NOVUS MRI
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code NVN·October 31, 2012
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 19, 2010
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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