BEUDAMED
    18 results · 31ms · Sources: EU EUDAMED, US FDA

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    BIOCERAMIC ORBITAL IMPLANT, ORBTEX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/65MM

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code JDP·August 28, 2015

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100540·Caddie, 8.5mm Screws

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 26, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·March 2, 2015

    IMPLANT, FIXATION DEVICE CONDYLAR PLATE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code JDP·February 23, 2017

    RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMPLANT, FIXATION DEVICE, CONDYLAR PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code JDP·June 1, 2015

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·April 5, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 23, 2014

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·June 1, 2011

    STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

    4.5MM VA-LCP CURVED CONDYLAR PLATE/6 HOLE/159MM/RIGHT

    FDA Adverse Event
    Injury ·SYNTHES MEZZOVICO·Product code HRS·July 24, 2015

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    SmartPath to dStream for 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 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