BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    ENGAGE/ENGAGE TR INTRODUCERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390800198·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08806390862585·

    CM DRIVE IMPLANT 3.5X8

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·November 8, 2017

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANDELA SPTL-1E PULSED DYE LASER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HOMEPUMP ECLIPSE, 400ML, 100ML/HR

    FDA Adverse Event
    Injury ·I-FLOW CORP.·Product code MEB·August 16, 2011

    UNKNOWN DEPUY HIP LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·May 14, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 23, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·May 19, 2011

    CHROMID® CARBA SMART

    FDA Adverse Event
    Malfunction ·BIOMERIEUX S.A.·Product code JSO·August 23, 2018

    The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·June 12, 2013

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    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

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025