11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Air Pressure Therapy System (VU-IPC04B)
FDA 510(k)
FDA Class 2
·Physical Medicine
CoRoent
FDA UDI
Nuvasive, Inc.·00887517578952·CoRoent Ant TLIF Ti, 14x13x32mm 0°
Syntec-Taichung Non-sterile Bone Plate and Screw Implants
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04719864684450·L & T-Plate(Right) 2.0
BioHorizons
FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236002411·External 3.5mm Direct Pick-up Screw
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HAKIM PROGRAMMABLE VALVE
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC·Product code JXG·November 11, 2014
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 12, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 29, 2023
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