BEUDAMED
    26 results · 22ms · Sources: EU EUDAMED, US FDA

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    HOTWIRE™ RF Guidewire

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Holder

    FDA UDI
    ADLER ORTHO SPA·08050507136933·CONDYLES HOLDER ASSEMBLY FOR UNIVERSAL HANDLE

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776412463·Set of 6.5mm Nathanson Retractors, Robotic Shaf...

    Spud

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101209·GOLF CLUB FOREIGN BODY SPUD

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04059993331703·ELVAREX 1/THIGH HIGH/OPEN TOE/SLIP FORM WITHOUT...

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167522409000·

    S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Iris Forceps

    FDA UDI
    ELMED INSTRUMENTS(PVT)LTD.·G165SU240900100·Intended Use: Iris Forceps are incredible eye i...

    SAMSUNG GALAXY WATCH 5 PRO (Z9NL)

    FDA Adverse Event
    Malfunction ·SAMSUNG ELECTRONICS AMERICA, INC.·Product code QDA·May 26, 2026

    TENCKHOFF CATH (10)

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code FJS·November 10, 2014

    CLINAC

    FDA Adverse Event
    Malfunction ·VARIAN MEDICAL SYSTEMS, INC.·Product code IYE·August 8, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·July 17, 2013

    OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile fluoroscopic C-Arm imaging system used to assist trained surgeons and other qualified physicians. The system is used to provide fluoroscopic Xray images and volumetric reconstructions during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    TOTAL KNEE REPLACEMENT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016

    PATIENT SPECIFIC TOTAL FEMUR

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018

    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025

    various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10 Degree Face Changing E1 Liner RingLoc Bi-Polar Ringloc Hi-Wall ArCom Liner RingLoc Hi-Wall ArComXL Liner RingLoc Hi-Wall E1 Liner Ringloc Neutral Max-Rom ArCom Liner RingLoc Neutral Max-Rom ArComXL Liner RingLoc Neutral Max-Rom E1 Liner Product Usage: For use in hip arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017