BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZEUS-O

    FDA UDI
    SPINAL ELEMENTS·00840916122270·Zeus-O Implant, 11 x 9 x 36mm

    Copper Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989028775·COPPER NITI 35 BAF 21X25LOLG PK10

    Posted Stainless Steel Archwire

    FDA UDI
    Ortho Arch Company Inc·D90911093617·.019 X .025 POSTED SS RIGHT FORM WIRES 36MM (10)

    GYNECARE TVT ABBREVO CONTINENCE SYSTEM

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

    MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

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

    GYNECARE TVT-ABBREVO MINI LCM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 30, 2021

    RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø11X360 MM X 125°

    FDA Adverse Event
    Injury ·STRYKER TRAUMA KIEL·Product code HSB·July 23, 2018

    EONC

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·May 8, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 23, 2014

    HEARTMATE II SYSTEM CONTROLLER, EU

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·April 20, 2011

    REVITAN, RASP, DISTAL, CURVED, 14/140

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·April 11, 2018

    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