BEUDAMED
    19 results · 29ms · Sources: EU EUDAMED, US FDA

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    SmartLinx Vitals Plus Patient Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AGC TRADITION KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304240872·

    Oticon

    FDA UDI
    Oticon A/S·05707131284310·H11V2 TI, BTE 13 WL 85 SIL

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100196·MCINTYRE SPECULUM OPEN WIRE

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100219·LIEBERMAN ASPIRATING SPECULUM K-WIRE

    STAXX IBL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RADIFOCUS GLIDEWIRE M

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

    COLIBRI

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·October 8, 2014

    DEPUY ASR XL FEM IMP SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 6, 2013

    ASR ACETABULAR IMPLANT 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 30, 2011

    DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509); Non-Ported Double Swivel Elbow for use with breathing circuits

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·May 24, 2023

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·January 29, 2019

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·September 8, 2016

    UNIVERSA SOFT URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK UROLOGICAL INC·Product code FAD·May 13, 2016

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·July 23, 2019

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015