BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    RT2 Trabeculite Titanium Cervical Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768499·GENUMEDI PSS GREEN V

    AGXO

    FDA UDI
    Oticon A/S·05707131289001·H110V2 TI, RITE 312 WL CBE AGXO

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE

    SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPAPLUS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·September 5, 2008

    SYNCHRON LX20 PRO SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·June 8, 2011

    ONCOLOGY SALVAGE SYSTEM - FEMORAL

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 27, 2017

    OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS - CEMENTED IM STEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·March 27, 2017

    ASAHI GLADIUS EX

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025

    ASAHI GLADIUS EX

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026

    Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·June 19, 2013