BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Pathway

    FDA UDI
    SPINAL ELEMENTS·00840916113032·Pathway ACIF 9mm, 7 degrees

    CASTENADA CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896003880·CASTENADA CLAMP SMALL DOUBLED CURVED JAW ANGLED...

    CASTENADA CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921009070·CASTENADA CLAMP SMALL DOUBLED CURVED JAW ANGLED...

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521009070·

    McKesson

    FDA UDI
    MCKESSON MEDICAL-SURGICAL INC.·00612479241893·Therapy Putty medium resistance level 4 oz

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857527898·AN Lordotic Spreader Size 8.5x28x4 mm, 6°

    SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0

    FDA 510(k)
    FDA Class 2 ·Neurology

    NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

    EDWARDS LIFESCIENCE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCE·Product code DYG·May 18, 2011

    ACTION PATCH SMART IONTOPHORESIS SYSTEM

    FDA Adverse Event
    Injury ·EMPI·Product code EGJ·August 7, 2008

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·March 14, 2011

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·October 15, 2025

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·October 15, 2025

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021