15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRESIDENT The Original
FDA 510(k)
FDA Class 2
·Dental
BBL™ CultureSwab™
FDA UDI
COPAN ITALIA SPA·38053326002015·CultureSwab Cary-Blair Agar Single Swab
Response BandLoc Spinal Fixation
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HARMONIC ACE 36CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 22, 2009
GALILEO® CAPTURING ROD
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·March 13, 2025
MARYLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC.·Product code GEI·October 31, 2008
AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL·Product code LFL·August 15, 2011
ATLAS II PLUS HF CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013
130° RADIOLUCENT TARGETING ARM
FDA Adverse Event
Malfunction
·ARTHREX, INC.·Product code HSB·August 12, 2024
PORTICO TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NPT·May 30, 2024
PORTICO TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL·Product code NPT·May 30, 2024
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Death
·ABBOTT MEDICAL·Product code NKM·April 30, 2026
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 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