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

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    VASOVIEW 5 HARVESTING CANNULA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Safco Royal 4-ply bibs

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310201433·Safco Royal bib 13x18 4ply aqua 500cs

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717101847·Burs FG 558, Pkg/100

    Humelock II Cemented Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037305720·K-WIRE CENTER GUIDE Ø43 mm

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450046562·

    MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM

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

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·January 22, 2024

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MPRI·Product code DTB·March 25, 2013

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 11, 2011

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·September 13, 2023

    MEDTRONIC NAVIGATION

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·October 6, 2021

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·August 13, 2021

    ARCHITECT C16000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·October 14, 2020

    Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, B-P Type II Talar Ankle Component: Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101, Size 2 B-P Type II Talar Ankle Component Catalog: 05-01-0102, Size 3 B-P Type II Talar Ankle Component Catalog: 05-01-0103, Size 4 B-P Type II Talar Ankle Component Catalog: 05-01-0104, Size 5 B-P Type II Talar Ankle Component Catalog: 05-01-0105, Size 6 B-P Type II Talar Ankle Component Catalog: 05-01-0106. BP Ankle System, BP Type II Ankle Bearing: 3x5mm BP Type II Ankle Bearing Catalog: 05-02-0103, 3x6mm BP Type II Ankle Bearing Catalog: 05-02-0113, 3x7mm BP Type II Ankle Bearing Catalog: 05-02-0123, 3x9mm BP Type II Ankle Bearing Catalog: 05-02-0143, 3x11mm BP Type II Ankle Bearing Catalog: 05-02-0163, 3x13mm BP Type II Ankle Bearing Catalog: 05-02-0183, 4x5mm BP Type II Ankle Bearing Catalog: 05-02-0104, 4x6mm BP Type II Ankle Bearing Catalog: 05-02-0114, 4x7mm BP Type II Ankle Bearing Catalog:05-02-0124, 5x5mm BP Type II Ankle Bearing Catalog: 05-02-0105, 5x7mm BP Type II Ankle Bearing Catalog: 05-02-0125, 5x9mm BP Type II Ankle Bearing Catalog: 05-02-0145. 5x6mm BP Type II Ankle Bearing Catalog 05-02-0106. 6x5mm BP Type II Ankle Bearing Catalog 05-02-0115. 6x6mm BP Type II Ankle Bearing Catalog 05-02-0116. 7x6mm BP Type II Ankle Bearing Catalog 05-02-0126. 9x6mm BP Type II Ankle Bearing Catalog 05-02-0146. 11x5mm BP Type II Ankle Bearing Catalog 05-02-0165. 11x6mm BP Type II Ankle Bearing Catalog 05-02-0166. 13x5mm BP Type II Ankle Bearing Catalog 05-02-0185. 13x6mm BP Type II Ankle Bearing Catalog 05-02-0186. BP Ankle System, B-P Type II Tibial Ankle Component Size 1 B-P Type II Tibial ankle Component Catalog: 05-03-0101, Size 2 B-P Type II Tibial ankle Component Catalog: 05-03-0102, Size 3 B-P Type II Tibial ankle Component Catalog: 05-03-0103, Size 4 B-P Type II Tibial ankle Component Catalog: 05-03-0104, Size 5 B-P Type II Tibial ankle Component Catalog: 05-03-0105, Size 6 B-P Type II Tibial ankle Component Catalog: 05-03-0106.

    FDA Recall
    Terminated ·Endotec, Inc.·Product code JWH·June 5, 2009

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018