BEUDAMED
    24 results · 34ms · Sources: EU EUDAMED, US FDA

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    TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DRG QUICKMIX

    FDA 510(k)
    FDA Class 2 ·Neurology

    NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PASS LP - LIGAPASS

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code JDQ·April 26, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·July 12, 2013

    MONARC SUBFASCIAL HAMMOCK

    FDA Adverse Event
    AMS·Product code OTN·May 8, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2011

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL·Product code MTA·August 13, 2008

    PASS LP - LIAPASS

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 14, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·November 12, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·February 20, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code FOZ·October 6, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·June 25, 2025

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026

    INTROCAN SAFETY® 3

    FDA Adverse Event
    Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·January 12, 2026

    5.5 EXP VERSE UNITIZED SET SCR

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    5.5 EXP VERSE SCR 6.0X45

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023