BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    MACH BRACKETS BRIGHT BRACKETS

    FDA 510(k)
    FDA Class 2 ·Dental

    Spherodon - M

    FDA UDI
    SILMET LTD·07290012207303·Dental Amalgam Capsules

    ProCopper

    FDA UDI
    SILMET LTD·07290016787573·Dental Amalgam Alloy

    Spherodon M Econom

    FDA UDI
    SILMET LTD·07290016787764·Dental Amalgam Capsules

    HIVOX EAR THERMOMETER, TS SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AS3700 ANESTHSIA DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

    OPTILENE 4/0 (1,5) 45CM DSMP16 (M) RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·February 25, 2021

    VDW.SILVER RECIPROC

    FDA Adverse Event
    Malfunction ·VDW GMBH·Product code EBW·August 25, 2023

    ASR UNI FEMORAL IMPL SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 20, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    VANGUARD PS OPEN BOX FEMORAL 70MM RIGHT INTERLOK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·June 10, 2011

    MICRUSFRAME10 5MM X 9.7CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·April 23, 2021

    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024