BEUDAMED
    16 results · 28ms · Sources: EU EUDAMED, US FDA

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    ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT

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

    SW

    FDA UDI
    SW SAFETY SOLUTIONS INC.·00616489004028·PowerChem Neoprene Exam Gloves, Small

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6911040402·CUBE PESSARY W/ DRAINAGE HOLES #2

    BiomarC®

    FDA UDI
    Carbon Medical Technologies, Inc.·00858015005110·Preloaded Carbon Tissue Marker, Distal Delivery

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065661·INTRAORAL ELASTICS 2,5 oz 5/16" blue

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0104020·Caddie, Large, 30mm

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0104020·Caddie, Large, 30mm

    Toilet Support Arms

    FDA UDI
    Ropox A/S·05707581014758·

    SMOOTH-FLO CIRCUIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST

    FDA 510(k)
    FDA Unclassified ·Unknown

    COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS

    FDA Adverse Event
    Malfunction ·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 29, 2025

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·April 8, 2013

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 7, 2008

    CE INFUSOR LV 5, 12 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·April 5, 2011

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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