BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    ONESTEP PEDIATRIC MFE'S

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306819582·Simpson-St. Mark's Retractor 9", w/Lip, Angled 15°

    TINA-QUANT ALPHA-1 ANTITRYPSIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BD LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 30, 2019

    ACTICON NEOSPINCTER

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·May 9, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 23, 2014

    SUPERTORQUE 5F MARKER BAND FLUSH CATHETER

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code DQO·June 2, 2011

    NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code BSP·August 5, 2025

    BD SYRINGE 30ML LL BNS

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 7, 2019

    Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·March 20, 2013

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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