BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171029311·PESSARY, RING #1, W/KNOB AND W/SUPPORT, 2"

    Bespa Charcot System

    FDA UDI
    Kapstone Manufacturing, LLC·00810041320391·Seg Column, Screw, 45

    SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SLEEPRIGHT

    FDA 510(k)
    FDA Unclassified ·Unknown

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·April 28, 2023

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 29, 2013

    PSI KIT: 8.5 FR X 4 (10 CM)

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code KGZ·June 22, 2011

    IMPLANTIUM

    FDA Adverse Event
    Injury ·DENTIUM·Product code DZE·September 3, 2008

    GALAXY G3 MINI 1.5MM X 4CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 24, 2020

    ASAHI GLADIUS EX

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025

    ASAHI GLADIUS EX

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026

    GALAXY G3 MINI 2.5MM X 4.5CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 29, 2020

    MICRUSFRAME10 6MM X 26CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·July 14, 2020

    da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015

    da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·April 15, 2015