15 results · 22ms · Sources: EU EUDAMED, 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