BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAXCUT CARBIDE BUR (100/pk) FG 33-1/2

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77811119161·MAXCUT CARBIDE BUR (100/pk) Shape: Inverted Con...

    TI TITAMAX EX IMPLANT (4.1)3.75X15

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·November 9, 2017

    SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES

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

    JOULE MULTI-PLATFORM SYSTEM

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

    PIPELINE

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code OUT·March 11, 2020

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code CBK·April 18, 2022

    Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare, LLC·June 15, 2022

    VITEK® 2 AST-ST01 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code LON·October 24, 2017

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 14, 2013

    EBICE MODEL 10D

    FDA Adverse Event
    Injury ·EBI, LLC·Product code ILO·June 2, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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