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

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    DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE

    FDA 510(k)
    FDA Class 1 ·Dental

    NexxZr™ / W-98-14-UT-D300-ML

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271139757·

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551139942·COMPASS BUSHING FOR sEEG

    E-BASIC SINGLE BREAST PUMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ELECSYS PRECICONTROL MULTIMARKER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BALL HEADS: MECTACER 01.29.210 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 22, 2023

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

    ASR ACETABULAR IMPLANT 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

    STERLING SL BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·May 25, 2011

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·August 23, 2016

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·April 14, 2016

    ASAHI CONFIANZA PRO 8-20

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·June 6, 2016

    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

    FDA Enforcement
    Class II ·Terminated·Cardio Medical Products·July 17, 2013

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021