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

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    AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER

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

    HemoCue® Hb 201 Microcuvettes

    FDA UDI
    Hemocue AB·17311091117325·HemoCue Hb 201 Microcuvettes 4x25 single

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·February 1, 2024

    EMULSION SB

    FDA 510(k)
    FDA Unclassified ·Unknown

    ASTRA TECH IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CM TITAMAX EX IMPLANT 3.75X9

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·November 9, 2017

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 26, 2019

    9611993-2024-111732

    FDA Adverse Event
    Injury ·NOBEL BIOCARE (PRODUCTION) AB·Product code DZE·September 26, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    PLMA DVC V11.51 1 N

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 7, 2013

    ACCU-CHEK MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2011

    TALENT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·August 14, 2008

    ANTI-A (MURINE MONOCLONAL) SERIES 1

    FDA Adverse Event
    Malfunction ·IMMUCOR·Product code KSZ·February 10, 2010

    MEDTRONIC ICD

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·December 7, 2023

    Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm. Milex Part Number: MXKPCONDS00 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum.

    FDA Enforcement
    Class III ·Terminated·Cooper Surgical, Inc.·April 3, 2013

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025