11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ERA® Implant Abutment Micro Angled Base, 4mm Cuff (W)
FDA UDI
STERNGOLD DENTAL LLC·00841549102790·Implant retained overdentures are an establishe...
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120270·Screwdriver blade - 1.5mm diam.
Bioplate®
FDA UDI
Bioplate, Inc.·M384812027CP0·Screwdriver blade - 1.5mm diam.
MODIFICATION TO XIA SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Wet Organics Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TMJ SMALL RIGHT FOSSA COMPONENT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·May 15, 2014
CONCERTO CRT-D DR AT
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·October 31, 2012
PUMP MMT-522NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 18, 2010
OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370
FDA Enforcement
Class II
·Ongoing·Osteomed, LLC·December 15, 2021
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