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

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    Medical Monitor (21HQ613D)

    FDA 510(k)
    FDA Class 2 ·Radiology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117384·Modular Knee Stem Pilot 13mm x 100mm

    Monkey Rings™ External Fixation System

    FDA UDI
    Paragon 28, Inc.·00889795011749·Modular Quick Adjust Strut, Short

    SacroFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361023371·Ø10MM SLOTTED FUSION SCREW, GEN II, SACROFUSE, ...

    Holder, Needle, TC, acc. Mayo-Hegar 16cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034064290·Holder, Needle, TC, acc. Mayo-Hegar 16cm ...

    ANTERIOR LUMBAR BUTTRESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMED GEMINI PCA

    FDA Adverse Event
    Injury ·IMED CORP.·Product code FRN·November 29, 1994

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 2, 2017

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 2, 2025

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 24, 2008

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 9, 2011

    ENERGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013

    PALMAZ STENT UNKNOWN

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code FGE·August 27, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·November 11, 2025

    AVIATOR PLUS PTA DILATATION CATHETER

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code LIT·October 2, 2012

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code NTE·October 2, 2012

    AVIATOR PLUS PTA DILATATION CATHETER

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code LIT·October 2, 2012

    JUGGERKNOT 1.4MM SHRT W/NDLS

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code MBI·March 16, 2020

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

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