BEUDAMED
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    RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Luxatemp® Ultra

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1109040·Temporary crown and bridge material automix sys...

    ACEMST1

    FDA UDI
    ACEM SPA·08050705890200·ACEMST1.1 FLEXIBLE ARM w/BATTERY TROLLEY

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00850038691042·

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306819476·Langenbeck Retractor 50mm x 11mm, 25cm (for use...

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172972380·

    SMARTXIDE 50 HS/MS

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

    ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE

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

    IVEDCO

    FDA Adverse Event
    IVEDCO·Product code FMF·April 19, 2005

    OCTRODE

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

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 2, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    SMARTXIDE 50 HS

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 30, 2023

    AVANTA FLUID MANAGEMENT INJECTION SYSTEM

    FDA Adverse Event
    Injury ·MEDRAD, INC.·Product code DXT·September 22, 2011

    Absorbable Collagen Sponge Provided As Intermediate to Another Company

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corporation·May 22, 2013

    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