BEUDAMED
    8,595 results · 99ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    S & F INC

    FDA registration
    S & F INC·3 products·🇰🇷 South Korea

    UNK_CELSIUS THERMOCOOL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·August 28, 2025

    SMART TOUCH UNIDIRECTIONAL SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 20, 2025

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·November 18, 2024

    BRAUN

    FDA Adverse Event
    Malfunction ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code FLL·August 12, 2021

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·November 13, 2019

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·November 13, 2019

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·November 13, 2019

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·November 13, 2019

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·November 13, 2019

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·November 13, 2019

    THERMOCOOL SF NAV

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·January 15, 2026

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·August 30, 2022

    UNK KNEE TIBIAL INSERT SIGMA

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·April 17, 2025

    THERMOCOOL SMARTTOUCH SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 31, 2026

    QDOT MICRO

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code OAE·March 15, 2024

    UNK_SMART TOUCH UNIDIRECTIONAL SF

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·June 22, 2023

    DECANAV ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·October 18, 2023

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·November 20, 2019

    Non-continuous ventilator accessories under the following brand names: a) RP-ComfortGel Gel Cushion M model number 1009050; b) RP-ComfortGel Gel Cushion P model number 1009048; c) RP-ComfortGel Gel Cushion S model number 1009049; d) RP-ComfortGel Silicone Flap L model number 1009109; e) RP-ComfortGel Silicone Flap M model number 1009054; and f) RP-ComfortGel Silicone Flap S model number 1009053. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007