BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    Fuse Endoscopic System with FuseBox Processor

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

    NA

    FDA UDI
    MAKO SURGICAL CORP.·00848486020552·ACETABULAR REAMER ¿ 56mm

    Denovo general purpose dental molar band

    FDA UDI
    Denovo Dental, Inc.·00810059290686·Denovo general purpose dental molar band - Mand...

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221044969·Unitek(TM) Molar Band General Purpose Narrow Re...

    PIEZOTOME

    FDA 510(k)
    FDA Class 2 ·Dental

    WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS

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

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 15, 2002

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 10, 2013

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·June 2, 2011

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·May 24, 2023

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 6, 2023

    HF-RESECTION ELECTRODE, LOOP

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 2, 2023

    Presource PBDS, General Laparoscopy, Kit, Circulator

    FDA Enforcement
    Class I ·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013

    dS Breast 16ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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