BEUDAMED
    13 results · 30ms · Sources: EU EUDAMED, US FDA

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    MatrixRIB Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131338839·SIYA 2, BTE 13 2.4G 85 C093

    BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIDWEST LOW SPEED ATTACHMENTS - CONTRA ANGLE SHEATH

    FDA Adverse Event
    Malfunction ·SIRONA DENTAL SYSTEMS GMBH·Product code EFB·April 20, 2023

    MAMBA? FLEX

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

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 21, 2014

    COYOTE? ES

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·June 26, 2013

    UNKNOWN SPINAL CORD STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·July 25, 2011

    BACT/ALERT MP - 419744

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

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024