BEUDAMED
    24 results · 21ms · Sources: EU EUDAMED, US FDA

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    MAMBA and MAMBA Flex Microcatheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAMBA? FLEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·September 11, 2025

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768451·GENUMEDI PSS GREEN I

    Oticon

    FDA UDI
    Oticon A/S·05707131338754·SIYA 1, BTE 13 2.4G 85 C090

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101063·KNAPP RETRACTOR 4-PRONG SHARP

    Paxeon Remedy

    FDA UDI
    PAXEON RECONSTRUCTION LLC·08177570201051·Remedy Stem Size 4 High Offset

    Remedy Hip Stem

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215053253·

    Remedy

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215008123·

    LinkBio Instrument

    FDA UDI
    Link Bio Corp·00810022402207·Starter Reamer, Tibial Cone

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111904010·Orion Stem, H/O (Lateralized) - Size 4

    ORTHOSS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    SKYLON Stem

    FDA UDI
    AMPLITUDE SAS·03701089520485·

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 26, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·July 25, 2011

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code LIT·October 21, 2014

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·December 1, 2017

    BACT/ALERT MP - 419744

    FDA Adverse Event
    Malfunction ·BIOMERIEUX INC.·Product code MDB·December 5, 2019

    DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·May 27, 2020

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020