BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    LZI Tramadol Enzyme Immunoassay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780182566·Integra® Jarit® Ribbon Retractor, 13", Hollow G...

    FAA Airline - 24 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588013237·FAA Airline - 24 Metal

    OmniTrustTM

    FDA UDI
    OMNI INTERNATIONAL CORP.·00810572003572·Nitrile Examination Glove Powder Free Large

    3-HOLE SPATULA INFILTRATION

    FDA UDI
    The Wells Johnson Company·B458201223000·Cannula, 3-Hole Spatula, Infiltration, specify ...

    ACULUX, MODEL AX3001, AX3002

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

    BELIMED STEAM STERILIZER, MODEL TOP 5000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2023

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 3, 2011

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3- PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 20, 2008

    TI COLLAR FOR 6MM DUAL-OPENINGIMPLANTS

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code NKB·July 2, 2013

    OPTIFLOW FILTERED NASAL INTERFACE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025

    OPTIFLOW FILTERED NASAL INTERFACE WITH CO2 SAMPLING

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 16, 2023

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·January 23, 2017

    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021