BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS

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

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169601321·SPACER 2110455 OLIF25 20MM 0 DEG 14X55

    Humelock II Cemented Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037307137·OSTEOTOME

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base

    SPAPLUS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

    BD INTIMA II¿ IV CATHETER 24G X 0.75 IN.

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·August 3, 2017

    UNKNOWN MICROCATHETER

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    GOBED+

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 25, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024