BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP

    FDA 510(k)
    FDA Class 2 ·Neurology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694000703·2.4mm x 22mm Locking Screw

    Mini-Mono®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70602221·Mini-Mono-Brackets Ricketts 'S' .018" 400 Brackets

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"

    Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection

    FDA UDI
    XERIDIEM MEDICAL DEVICES, INC.·00827002447851·Entuit Gastrostomy BR Balloon Retention Feeding...

    OHMEDA MEDICAL GIRAFFE INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UM-L25

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DESARA BLUE TV

    FDA Adverse Event
    Injury ·CALDERA MEDICAL INC.·Product code OTN·December 5, 2019

    CONFIDA BRECKER CURVE GUIDEWIRE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code DQX·June 5, 2025

    EON

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 11, 2013

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD., UK·Product code KWY·June 13, 2008

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·April 15, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP60

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021