BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    Garion Image-Intensified Fluoroscopic X-Ray System, Mobile

    FDA 510(k)
    FDA Class 2 ·Radiology

    Epimed

    FDA UDI
    EPIMED INTERNATIONAL, INC·00818788020741·20g RW x 8.0" Day Needle Bullet Tip Coudé®

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112656·BARRON CORNEAL PUNCH 8.5MM

    36M - Class B 21 Lawson - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620800·36M - Class B 21 Lawson - Metal

    Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Imaging Plate Scanner, i-Scan

    FDA 510(k)
    FDA Class 2 ·Dental

    COMPREHENSIVE REVERSE HUMERAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·August 7, 2018

    COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM +5MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·August 7, 2018

    COMP RVS HMRL TI TRAY 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·August 7, 2018

    SPIDERFX EMBOLIC PROTECTION DEVICE

    FDA Adverse Event
    Injury ·EV3 INC.·Product code NTE·November 6, 2008

    ATW STEERABLE GUIDEWIRE

    FDA Adverse Event
    Injury ·CORDIS CORPORATION·Product code DQX·August 24, 2011

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2014

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code FMZ·June 30, 2021

    LIAISON SARS-COV-2 AG

    FDA Adverse Event
    Malfunction ·DIASORIN ITALIA S.P.A.·Product code QKP·March 19, 2024

    Oxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and G603 Work Chambers Oxygen Sensors supplied for use in the following incubator and work chamber products; G185 Standard 110V, G185 SensorTech 110V, G185 Standard 230V, G185 SensorTech 230V, G210 InviCell Standard, G210 InviCell Standard US, G210 Invicell Plus Optional pH and External Monitoring, G603 Work Chamber 115V, & G603 Work Chamber 230V. [CooperSurgical part numbers K22400-110, K22200-110, K22400-230, K22200-230, K59500, K59700, K60000, 3.641.831.153, & 3.641.832.153].

    FDA Enforcement
    Class II ·Terminated·CooperSurgical, Inc.·August 25, 2021

    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

    Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210. Component: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS).

    FDA Enforcement
    Class II ·Ongoing·LivaNova USA, Inc.·February 5, 2025