BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    Disposable Injection Needles

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

    Young Dental

    FDA UDI
    YOUNG DENTAL MANUFACTURING I, LLC·00302732322000·TRACE-28 DISC TAB BULK PK

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00842894182253·

    BodiTrak

    FDA UDI
    Vista Medical Ltd·07540150601441·Hi-Res Seat

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702777765·ELVAREX 2/KNEE HIGH/SLANT-CLOSED TOE-ELEPHANTIA...

    G185

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120109·Incubator for assisted reproduction

    G185

    FDA UDI
    RESEARCH INSTRUMENTS LIMITED·05060554120116·Incubator for assisted reproduction

    PRO HMPV+ ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VALIANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·June 24, 2013

    TALENT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·June 25, 2013

    VALIANT CAPTIVIA

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·August 5, 2013

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 2, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.·Product code ITJ·December 5, 2012

    S-ROM M HEAD 36MM +0

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code LPH·November 6, 2014

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·February 28, 2020

    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

    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

    Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle of Corinz oral rinse. Product Usage: The mouthpaste is used to clean teeth, gums, and the tongue.

    FDA Recall
    Terminated ·Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804·Product code NSB·December 5, 2018

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020