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

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    TUBING, DIALYSATE (AND CONNECTOR)

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

    Safco T&F Bur - 12 Bladed

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310220683·Safco T&F bur - 12 bladed, carbide, #7901 needl...

    PERSONA™ Trabecular Metal™

    FDA UDI
    Zimmer, Inc.·00889024230248·

    PERSONA™ Trabecular Metal™

    FDA UDI
    Zimmer, Inc.·00889024230231·

    Persona® Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024470132·

    Persona® Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024470149·

    WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S

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

    ORG-9200A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 26, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP.·Product code MKJ·March 10, 2011

    COMB 40+

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERATE GMBH·Product code MCM·March 27, 2008

    PERSONA NATURAL TRABECULAR METAL TWO-PEG POROUS FIXED BEARING TIBIA

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code OIY·November 18, 2016

    TIBIA TRABECULAR METAL TWO-PEG POROUS FIXED BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·February 27, 2024

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·January 31, 2018

    Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 28, 2018

    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

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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